Is this your brand? Sign in to claim ownership.

POINTE SCIENTIFIC, INC.

Last updated May 24, 2026

What POINTE SCIENTIFIC, INC. makes

Pointe Scientific, Inc. manufactures in vitro diagnostics (IVDs) for clinical chemistry and drug testing, including reagents, kits, and calibrators for measuring triglycerides, bilirubin, liver enzymes (ALT, AST), creatinine, calcium, phosphate, uric acid, lactate dehydrogenase, and methadone metabolites. Their products also cover drug-of-abuse testing, such as cannabinoids (THC) and calibrators for spectrophotometric assays.

The company’s portfolio includes Class I and Class II devices, all listed in the FDA’s Unique Device Identifier (UDI) database. Pointe Scientific, Inc. is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Pointe Scientific, Inc. manufacture?

Pointe Scientific, Inc. specializes in in vitro diagnostics (IVDs) used in clinical chemistry and drug testing. Their products include reagents, kits, and calibrators for measuring substances like triglycerides, bilirubin, liver enzymes (such as ALT and AST), creatinine, calcium, phosphate, uric acid, and lactate dehydrogenase. They also provide reagents and controls for drug-of-abuse testing, including cannabinoids (THC) and methadone metabolites. These devices are designed for use in laboratory settings to aid in diagnostic testing.

Where is Pointe Scientific, Inc. based?

Pointe Scientific, Inc. is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it helps determine the applicable regulatory framework for its devices, particularly when considering compliance with U.S. regulations like those enforced by the FDA.

Which regulatory registries list Pointe Scientific, Inc.’s devices?

Pointe Scientific, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their distribution and helps ensure transparency and traceability in the regulatory process. Listing in this database is a requirement for Class I and Class II devices in the U.S.

How are Pointe Scientific, Inc.’s devices classified under U.S. regulations?

Pointe Scientific, Inc.’s devices fall into two primary classification categories under U.S. regulations: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure their safety and effectiveness. The classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the duration of use.

What is the purpose of the reagents and controls produced by Pointe Scientific, Inc.?

The reagents and controls produced by Pointe Scientific, Inc. serve critical roles in clinical diagnostics. Reagents are used in laboratory tests to react with patient samples to produce measurable results, such as enzyme activity or substance concentrations (e.g., triglycerides or bilirubin). Controls, like calibrators, ensure the accuracy and reliability of these tests by providing reference values for comparison. For example, a cannabinoids (THC) control helps validate the performance of drug testing assays, ensuring consistent and accurate results.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: medtestdx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-445-9853
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 045623154

Catalogue (769)

Page 14 of 16

Device	Model / Reference	Registries	Class	Status
Pointe Propoxyphene (PPX) Calibrator (1000 ng/mL) High	60-PP0250-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. Rubella IgG	T8003-96	FDA UDI	Class II	Active
Pointe Oxycodone Control (75 ng/mL)	60-OX0484-5	FDA UDI	Class I	Active
Pointe Carbon Dioxide on the BS480	14-C7502-160	FDA UDI	Class II	Active
Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High	60-AC0590-5	FDA UDI	Class II	Active
Pointe Creatinine for BS480	14-C7539-432	FDA UDI	Class II	Active
Pointe Scientific, Inc. Urine Chemistry Controls	P7582-CTL	FDA UDI	Class I	Active
Pointe Multi-Analyte E DAU Negative Calibrator	60-MA1782-15	FDA UDI	Class II	Active
Pointe Cannabinoids (THC) Calibrator (50 ng/mL)	60-TH0150-5	FDA UDI	Class II	Active
Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL)	60-BA0286-5	FDA UDI	Class II	Active
Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL)	60-OP0666-5	FDA UDI	Class II	Active
Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low	60-AC0584-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. Magnesium Std	M7527-STD	FDA UDI	Class I	Active
Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL)	60-TH0152-5	FDA UDI	Class II	Active
ALT R2 (w/ssa#)	13-A7526-R2-125	FDA UDI	Class I	Active
Pointe Methamphetamine Reagent Set	60-MP0700-100	FDA UDI	Class II	Active
Pointe Methadone Calibrator (600 ng/mL)	60-ME0228-5	FDA UDI	Class II	Active
Pointe Opiates 300 Level 1 Control (Morphine 225 ng/mL)	60-OP0054-5	FDA UDI	Class I	Active
Pointe Cannabinoid (THC) Reagent Set	60-CA0140-100	FDA UDI	Class II	Active
Pointe Scientific, Inc. Toxoplasma IgG	T8001-96	FDA UDI	Class II	Active
Pointe Scientific, Inc. Glucose Hex	13-G7517-120	FDA UDI	Class II	Active
POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L)	C7568-STD	FDA UDI	Class II	Active
Pointe Hydrocodone 100 Calibrator (150 ng/mL)	60-HY0768-5	FDA UDI	Class II	Active
Alk Phos R1 (w/ssa#)	13-A7516-R1-500	FDA UDI	Class II	Active
Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL)	60-AM0216-5	FDA UDI	Class I	Active
Pointe Norbuprenorphine High Calibrator (75 ng/mL)	60-NB0558-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. GGT R1	13-G7571-R1-120	FDA UDI	Class I	Active
Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL)	60-BA0290-5	FDA UDI	Class II	Active
Pointe Scientific, Inc. Lipoprotein (a)	L7597-40	FDA UDI	Class II	Active
Pointe Scientific, Inc. Rubella IgM	T8004-96	FDA UDI	Class II	Active
Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1	60-EC0334-5	FDA UDI	Class I	Active
Pointe Benzodiazepine Control (Oxazepam 400 ng/mL)	60-BZ0272-5	FDA UDI	Class I	Active
POINTE SCIENTIFIC Ammonia Standard 1	A7553-STD100	FDA UDI	Class I	Active
Pointe Methadone Calibrator (300 ng/mL)	60-ME0226-5	FDA UDI	Class II	Active
Pointe GGT on BS480	14-G7571-200	FDA UDI	Class I	Active
Pointe Multi-Analyte Set D Urine DAU Level 1 Control	60-MA1754-15	FDA UDI	Class I	Active
Pointe Opiates 2000 Reagent Set	60-OP0660-100	FDA UDI	Class II	Active
Pointe Cocaine Metabolite 150 Reagent Set	60-CC0680-100	FDA UDI	Class II	Active
Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL)	60-CC0696-5	FDA UDI	Class I	Active
Pointe Scientfic, Inc. Lipid Controls	L7580-18	FDA UDI	Class I	Active
Pointe 6-Acetylmorphine Reagent Set	60-AC0580-100	FDA UDI	Class II	Active
Pointe Amylase on BS480 Analyzer	14-A7564-120	FDA UDI	Class II	Active
Pointe Cocaine Metabolite Reagent Set	60-CC0060-100	FDA UDI	Class II	Active
Pointe Methadone Metabolite (EDDP) Calibrator (50 ng/mL) Low	60-MM0404-5	FDA UDI	Class II	Active
Pointe Direct Bilirubin for BS480	14-HB936-200	FDA UDI	Class II	Active
Liquid Ggt (gamma Glutamyl Transferase) Reagent Set	K973157	FDA 510(k)	Class I	Active
Liquid Glucose (oxidase) Reagent Set	K970781	FDA 510(k)	Class II	Active
Liquid Amylase Reagent Set	K930475	FDA 510(k)	Class II	Active
Direct Bilirubin	K860257	FDA 510(k)	Class II	Active
Carbon Dioxide Reagent	K896812	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (81)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 19, 2015	Z-2487-2015	—	terminated	A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.
Mar 13, 2015	Z-2764-2015	—	terminated	Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
Dec 12, 2014	Z-2773-2015	—	terminated	Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Dec 1, 2009	Z-0912-2010	—	terminated	A process deviation occurred during the production of the R1 component which may affect its performance.
Dec 1, 2009	Z-1035-2010	—	terminated	An additional 10% picric acid was added to the R2 component during production.
Dec 1, 2009	Z-0913-2010	—	terminated	A process deviation occurred during the production of the R1 component which may affect its performance.
Dec 1, 2009	Z-1036-2010	—	terminated	An additional 10% picric acid was added to the R2 component during production.
Nov 16, 2009	Z-0899-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0904-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0900-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0901-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0905-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0906-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0903-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 16, 2009	Z-0902-2010	—	terminated	Turbidity formation could occur, resulting in invalid test results being reported out.
Nov 10, 2009	Z-0860-2010	—	terminated	The firm initiated the recall due to the presence of visible contamination of the product.
Nov 10, 2009	Z-1042-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Nov 10, 2009	Z-0859-2010	—	terminated	The firm initiated the recall due to the presence of visible contamination of the product.
Nov 10, 2009	Z-1043-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Nov 10, 2009	Z-1041-2010	—	terminated	Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Oct 19, 2009	Z-0104-2010	—	terminated	There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
Jul 29, 2009	Z-1014-2010	—	terminated	R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
Feb 2, 2009	Z-1202-2009	—	terminated	The product performance fails due to precipitation of the R2 component.
Jan 29, 2009	Z-1200-2009	—	terminated	The R1 reagent has microbial contamination.
Jan 29, 2009	Z-1201-2009	—	terminated	The R1 reagent has microbial contamination.
Nov 3, 2008	Z-1091-2009	—	terminated	The product is unable to maintain the specification for linearity through the shelf life of the product.
Sep 10, 2008	Z-0219-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0220-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0224-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0223-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0221-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Sep 10, 2008	Z-0222-2009	—	terminated	The inability of the product to maintain stated performance specifications through the stated shelf life.
Aug 25, 2008	Z-0172-2009	—	terminated	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Aug 25, 2008	Z-0171-2009	—	terminated	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Feb 7, 2008	Z-1360-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1356-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1354-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1353-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1357-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1355-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1359-2008	—	terminated	May be contaminated with microorganisms.
Feb 7, 2008	Z-1358-2008	—	terminated	May be contaminated with microorganisms.
Dec 14, 2007	Z-1116-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1117-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1111-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1113-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1112-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1110-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1114-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Dec 14, 2007	Z-1115-2008	—	terminated	Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Jun 12, 2006	Z-1454-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1455-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1458-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1459-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1456-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 12, 2006	Z-1457-06	—	terminated	Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Jun 9, 2006	Z-1392-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1544-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1395-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1397-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1393-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1547-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1391-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1548-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1388-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1396-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1549-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1394-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1545-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1389-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 9, 2006	Z-1546-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1543-06	—	terminated	Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
Jun 9, 2006	Z-1390-06	—	terminated	The reagent may be contaminated with microorganisms.
Jun 7, 2006	Z-1328-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1330-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1326-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1329-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1333-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1327-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1332-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.
Jun 7, 2006	Z-1331-06	—	terminated	Product does not meet performance specifications through its labeled expiration period.