← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

QUANTIMETRIX CORP.

US

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)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Immusure K973894
FDA 510(k)
Class IActive
Modification To Quantimetrix Urine Drugs Of Abuse Control K060417
FDA 510(k)
Class IActive
Prostat Control K943394
FDA 510(k)
Class IActive
Human Serum Cardioactive Drug Control K843679
FDA 510(k)
Class IActive
Preciset Dat Amphetamine K030826
FDA 510(k)
Class IIActive
Sweat Controls For Cystic Fibrosis Testing K943925
FDA 510(k)
Class IActive
Quanttest Total Protein Assay K853932
FDA 510(k)
Class IIActive
Preciset Dat Plus K021393
FDA 510(k)
Class IIActive
Synovialscopics, Synovial Fluid Control K010598
FDA 510(k)
Class IIActive
Quantimetrix Human Serum Chemistry Control K853931
FDA 510(k)
Class IActive
Quantimetrix Ammonia Controls K913346
FDA 510(k)
Class IActive
Quantimetrix Drug Free Human Urine Control K861420
FDA 510(k)
Class IActive
Spinal Fluid Total Protein Control K831527
FDA 510(k)
Class IActive
Dropper A1c Diabetes Control K103744
FDA 510(k)
Class IActive
Spinalscopics K970862
FDA 510(k)
Class IActive
Quantimetrix Biuret Serum Total Protein Assay Kit K853930
FDA 510(k)
Class IIActive
Quantimetrix C-Clear(tm) K931523
FDA 510(k)
Class IActive
Complete D 25-Oh Vitamin D Control K113177
FDA 510(k)
Class IActive
Quantimetrix Human Serum Therapeutic Drug Control K853933
FDA 510(k)
Class IActive
Aution Check Plus K142262
FDA 510(k)
Class IActive
Human Serum Anticonvulsant Drug Control K843818
FDA 510(k)
Class IActive
Salicylate Assay Kit K831336
FDA 510(k)
Class IIActive
Glycohemosure Hba1c Control K032791
FDA 510(k)
Class IIActive
Quantimetrix Nicosure Cotinine Urine Control K062942
FDA 510(k)
Class IActive
Quantimetrix Urinalysis Microscopics Control K925256
FDA 510(k)
Class IActive
Quantimetrix Human Bilirubin Control I & Ii Liquid K860942
FDA 510(k)
Class IActive
Lipoprint System, Ldl Subfractions K010337
FDA 510(k)
Class IActive
Urine Total Protein Control K831526
FDA 510(k)
Class IActive
Acetaminopher Assay Kit K832045
FDA 510(k)
Class IIActive
Human Serum Electrolyte Control-Liquid K834505
FDA 510(k)
Class IActive
Assure Urine Hcg Control K941130
FDA 510(k)
Class IActive
Modification To Lipoprint System, Ldl Subfractions K013662
FDA 510(k)
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Dec 21, 2017Z-2257-2018—terminated

The kits contained an incorrect lot of Dropper Plus Level 1 vials

Jun 1, 2007Z-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, 2007Z-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, 2007Z-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, 2007Z-0513-2009—terminated

This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.