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 15 of 16

Device	Model / Reference	Registries	Class	Status
Bun (liquid) Reagent Set	K972671	FDA 510(k)	Class II	Active
Alt (sgpt)	K813495	FDA 510(k)	Class I	Active
Naphthyl Phosphate, Acid Phosphatase	K863832	FDA 510(k)	Class II	Active
Ldh-L	K813496	FDA 510(k)	Class II	Active
Liquid Glucose (hexokinase) Reagent Set	K971754	FDA 510(k)	Class II	Active
Autohdl Cholesterol Reagent Set	K992002	FDA 510(k)	Class I	Active
Ammonia/Alcohol Control Set	K070504	FDA 510(k)	Class I	Active
Microprotein Reagent Set	K070757	FDA 510(k)	Class II	Active
Creatinine	K830556	FDA 510(k)	Class II	Active
Diazo Colorimetry, Bilirubin	K914873	FDA 510(k)	Class II	Active
Diazo Colorimetry, Billirubin	K832870	FDA 510(k)	Class II	Active
Alcohol Reagent Set	K972725	FDA 510(k)	Class II	Active
Amylase	K832889	FDA 510(k)	Class II	Active
Hemoglobin A1c Reagent Set	K031539	FDA 510(k)	Class II	Active
Amylase Eps-G7 (liquid) Reagent Set, (hitachi Analyzers)	K023396	FDA 510(k)	Class II	Active
Liquid Ast (sgot)reagent Set	K941132	FDA 510(k)	Class II	Active
Auto Hdl Cholesterol Calibrator	K970933	FDA 510(k)	Class II	Active
Glucose Oxidase	K810674	FDA 510(k)	Class II	Active
Liquid Ldh-L Reagent Set	K973589	FDA 510(k)	Class II	Active
Modification To Liquid Glucose (hexokinase) Reagent Set	K002199	FDA 510(k)	Class II	Active
Ast(sgot) In Vitro Diag. Reagent Set	K813405	FDA 510(k)	Class II	Active
Alkaline Phosphatase	K812452	FDA 510(k)	Class II	Active
Psi Amylase Reagent	K864464	FDA 510(k)	Class II	Active
Apolipoprotein A1 And Apolipoprotein B Reagents And Calibrators	K061377	FDA 510(k)	Class I	Active
Total Bilirubin Reagent Set	K040391	FDA 510(k)	Class II	Active
Liquid Alkaline Phoshatase Reagent Set	K973588	FDA 510(k)	Class II	Active
Psi Total Protein Reagent	K822468	FDA 510(k)	Class II	Active
Magnesium	K853592	FDA 510(k)	Class I	Active
Psi Albumin Reagent	K822471	FDA 510(k)	Class II	Active
Hemoglobin	K851432	FDA 510(k)	Class II	Active
Pointe 750 Glycometer	K920449	FDA 510(k)	Class II	Active
Microalbumin Reagent Set And Calibrators	K023860	FDA 510(k)	Class II	Active
C-Reactive Protein (high Sensitivity) Reagent Set	K002651	FDA 510(k)	Class II	Active
Lipase Hydrolysis/Glycerol Kinase	K832871	FDA 510(k)	Class I	Active
Lipase	K812794	FDA 510(k)	Class I	Active
Gamma Glutamy Transpeptidase	K812296	FDA 510(k)	Class I	Active
Glycohemoglobin, In-Vitro Diagnostic Reagent Set	K860572	FDA 510(k)	Class II	Active
Hexokinase, Glucose	K832872	FDA 510(k)	Class II	Active
Carbon Dioxide Reagent	K896590	FDA 510(k)	Class II	Active
Amylase	K910158	FDA 510(k)	Class II	Active
Psi Inorganic Phosphorus	K822470	FDA 510(k)	Class I	Active
Uric Acid Reagent Set	K812430	FDA 510(k)	Class I	Active
Creatine Kinase-Mb (ck-Mb) Reagent Set	K935463	FDA 510(k)	Class II	Active
Urea Nitrogen (bun)	K812341	FDA 510(k)	Class II	Active
Cresolphthalein Complexone, Calcium	K874131	FDA 510(k)	Class II	Active
Hdl Cholesterol Reagent	K812574	FDA 510(k)	Class I	Active
Multi-Analyte Chemistry Calibrator	K070207	FDA 510(k)	Class II	Active
Enzymatic Cholesterol	K810673	FDA 510(k)	Class I	Active
Creatine Kinase (ck) Reagent Set	K930660	FDA 510(k)	Class II	Active
Uric Acid (liquid) Reagent Set	K970560	FDA 510(k)	Class I	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.