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QUANTIMETRIX CORP.

Last updated September 17, 2026

What QUANTIMETRIX CORP. makes

Quantimetrix Corp. manufactures in vitro diagnostic (IVD) controls and reagents for clinical chemistry and urinalysis testing. Their products include urine analyte controls, urine sediment controls, protein assays, bilirubin controls, ammonia controls, and ethanol controls, as well as specialized kits for lipid profiling and enzyme spectrophotometry. These items are designed for quality assurance in laboratory settings, ensuring accurate test results across various diagnostic procedures.

The company’s portfolio consists of Class I and Class II devices, regulated under FDA pathways including the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. Their products are listed in the FDA’s regulatory databases, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from 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 Quantimetrix Corp. manufacture?

Quantimetrix Corp. specializes in in vitro diagnostic (IVD) controls and reagents used primarily for clinical chemistry and urinalysis testing. Their products include urine analyte controls, urine sediment controls, protein assays (such as total protein and enzyme spectrophotometry kits), bilirubin controls, ammonia controls, ethanol controls, and specialized lipid profiling kits. These devices are designed to ensure quality assurance and accuracy in laboratory testing environments.

Where is Quantimetrix Corp. based, and how does that affect its regulatory standing?

Quantimetrix Corp. is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations, including pathways like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. The company’s location ensures compliance with U.S. medical device authorization requirements, which are reflected in the FDA’s regulatory databases where its products are listed.

Which regulatory registries or databases list Quantimetrix Corp.’s devices?

Quantimetrix Corp.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries confirm that the company’s products meet U.S. authorization requirements for medical devices, ensuring transparency and compliance with regulatory standards.

How are Quantimetrix Corp.’s devices classified under FDA regulations?

Quantimetrix Corp.’s devices fall into two primary FDA device classes: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes before authorization.

What is the primary purpose of the devices manufactured by Quantimetrix Corp.?

The primary purpose of Quantimetrix Corp.’s devices is to serve as quality control tools for clinical laboratories. These IVD controls and reagents are used to verify the accuracy, precision, and reliability of diagnostic tests—such as urinalysis, clinical chemistry assays (e.g., protein, bilirubin, ammonia), and lipid profiling—ensuring consistent and trustworthy test results for patient care.

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

Information

Country: US
Address: 2005 Manhattan Beach Blvd, REDONDO BEACH, CA, 90278
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2020715
DUNS Number: —

Catalogue (82)

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Device	Model / Reference	Registries	Class	Status
Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL	1440-02	FDA UDI	Class I	Active
Ammonia Alcohol Control Level 3 Set 3x5mL	1313-31	FDA UDI	Class I	Active
QuanTtest Red Pyrogallol Red Reagent	5210-12	FDA UDI	Class II	Active
Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL	1290-01	FDA UDI	Class I	Active
QuanTtest Human Protein Standards Set	3410-02	FDA UDI	Class II	Active
Lipoprint LDL Subfractions Kit 4x25 tests	48-7002	FDA UDI	Class I	Active
QuanTscopics Control Level 2 Set 4x120mL	1482-41	FDA UDI	Class I	Active
Pediatric Bilirubin Control Level 1 Set 3x3mL	1331-31	FDA UDI	Class I	Active
Chromascopics Control Level 1&2 Set 4x120mL (Domestic)	1540-02	FDA UDI	Class I	Active
Dropper Spinal Fluid Control Level 1&2 Set 2x3mL	1450-01	FDA UDI	Class I	Active
Dipper POCT Level 1&2 Set 62x1.5mL	1400-01	FDA UDI	Class I	Active
Lipoprint System Buffer 4x16.5g	48-9519	FDA UDI	Class I	Active
Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL	1510-02	FDA UDI	Class I	Active
QuanTtest Red Reagent Total Protein Assay System	2210-02	FDA UDI	Class II	Active
Dropper Urine Chemistry Control Level 1&2 Set 2x10mL	1430-01	FDA UDI	Class I	Active
Microbumin Microalbumin Control Level 1&2 Set 10x7mL	1250-01	FDA UDI	Class I	Active
Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL	1440-04	FDA UDI	Class I	Active
Pediatric Bilirubin Control Level 1&2 Set 2x3mL	1330-01	FDA UDI	Class I	Active
Dropper Spinal Fluid Control Level 1 Set 3x3mL	1451-31	FDA UDI	Class I	Active
Dropper Urine Chemistry Control Level 2 Set 3x25mL	1432-32	FDA UDI	Class I	Active
Dropper Urine Chemistry Control Level 2 Set 3x10mL	1432-31	FDA UDI	Class I	Active
Ammonia Alcohol Control Level 2 Set 3x5mL	1312-31	FDA UDI	Class I	Active
Sweat Control Level 1, 2, & 3 Set 9x3mL	1190-01	FDA UDI	Class I	Active
Ammonia Alcohol Control Level 1 Set 3x5mL	1311-31	FDA UDI	Class I	Active
Dropper Urine Chemistry Control Level 1 Set 3x10mL	1431-31	FDA UDI	Class I	Active
Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL	1470-02	FDA UDI	Class I	Active
Spinalscopics Control Level 1 Set 3x3mL	1461-31	FDA UDI	Class II	Active
Chromascopics Control Level 1&2 Set 4x120mL (International)	1540-01	FDA UDI	Class I	Active
Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL	1470-01	FDA UDI	Class I	Active
Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL	1440-03	FDA UDI	Class I	Active
Chromascopics Control Level 1&2 Set 2x25mL (International)	1540-03	FDA UDI	Class I	Active
Liposure Serum Lipoprotein Control Level 1 4x0.5mL	48-7060	FDA UDI	Class I	Active
Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL	1442-61	FDA UDI	Class I	Active
QuanTscopics Control Level 1 Set 4x120mL	1481-41	FDA UDI	Class I	Active
Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL	1440-01	FDA UDI	Class I	Active
QuanTtest Red Pyrogallol Red Reagent	5210-12	FDA UDI	Class II	Active
Pediatric Bilirubin Control Level 2 Set 3x3mL	1332-31	FDA UDI	Class I	Active
Dropper Spinal Fluid Control Level 2 Set 3x3mL	1452-31	FDA UDI	Class I	Active
Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL	1440-06	FDA UDI	Class I	Active
Dipper POCT Level 1&2 Set 20x1.5mL	1400-02	FDA UDI	Class I	Active
Dropper Urine Chemistry Control Level 1 Set 3x25mL	1431-32	FDA UDI	Class I	Active
QuanTtest Human Protein Standards Set	3410-02	FDA UDI	Class II	Active
Spinalscopics Control Level 2 Set 3x3mL	1462-31	FDA UDI	Class I	Active
Quantimetrix Blood Glucose Controls	K932623	FDA 510(k)	Class II	Active
Quantimetrix Drug Free Serum Control	K863388	FDA 510(k)	Class I	Active
Cardiasure Cardiac Markers Control	K993723	FDA 510(k)	Class I	Active
Modification To Quantimetrix Cardiasure Cardiac Marker	K062751	FDA 510(k)	Class I	Active
Dropper hsCRP High Sensitivity CRP Control	K152117	FDA 510(k)	Class I	Active
Quantimetrix Bromeresol Purple Albumin	K830934	FDA 510(k)	Class II	Active
Quantimetrix Serum Enzyme Control	K880701	FDA 510(k)	Class I	Active

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Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (5)

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

Quantimetrix Corp. has five recall records listed in the FDA database, all initiated between June 1, 2007, and December 21, 2017, with each marked as terminated. The reasons cited include an incorrect lot of Dropper Plus Level 1 vials in one instance and efficacy concerns related to stabilized erythrocytes, leukocytes, and lymphocytes in another product group. The remaining three records lack publicly filed reasons in the provided data.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 21, 2017	Z-2257-2018	—	terminated	The kits contained an incorrect lot of Dropper Plus Level 1 vials
Jun 1, 2007	Z-0516-2009	—	terminated	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
Jun 1, 2007	Z-0515-2009	—	terminated	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
Jun 1, 2007	Z-0514-2009	—	terminated	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
Jun 1, 2007	Z-0513-2009	—	terminated	This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.