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Address: 107-127 N. Amphlett Blvd., San Mateo, California 94401, USA
www.eylabs.com |
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Phone: +1-(650)-342-3296, (800)-821-0044
Year Established: 1978
Annual Revenues: USD 1-5 Million
Employee Count: ~10
Quality: ISO 9001, CE Certified
Products: Gonorrhea Test Kits, Swabs, Gonorrhea Test Kits, Diagnostic Test Kits, Neisseria Gonorrhoeae Identification Kit (FDA Code:
JSX), Oxidase Test Device for Gonorrhea (FDA Code:
LGA), Streptococcal Multiple Exoenzyme Test (FDA Code:
GTP), ...
Ey Laboratories, Inc. produces rapid, simple & stable diagnostic test kits for visual and qualitative tests. We are an ISO 9001, CE MARK certified company. We offer products such as pure erythrina cri
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Address: 201 Grove Road, Thorofare, New Jersey 08086, USA
www.akersbiosciences.com |
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Phone: +1-(856)-848-8698
FDA Registration: 2247413 Year Established: 1989
Annual Revenues: USD 10-25 Million
Employee Count: ~40
Products: Rheumatoid Factor (RF), Mouse Rheumatoid Factor (RF) ELISA Kit, BreathScanr Alcohol Detector, Breath Alcohol Detection System, Sugar Monitoring Test Strip, Insulin Test Strip, ...
Akers Biosciences, Inc. provides two rapid manual assays into the clinical laboratory, which include Pifa® Heparin/PF4 rapid assay and the lithium system. We offer products such as breathscanr, PI
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Address: 14 Prentice St., PO Box 748, Norwich, New York 13815-2024, USA
www.culturekits.com |
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Phone: +1-(607)-336-1422, 888-680-6853
Year Established: 1983
Annual Revenues: < USD 1 Million
Employee Count: ~10
Products: Antibiotic Sensitivity Disc Dispenser, Antimicrobial Susceptibility Test Culture Media (FDA Code:
JSO), Bacterial Diagnostic Test, Enriched Culture Media (FDA Code:
KZI), Mueller Hinton Agar Broth Culture Media (FDA Code:
JTZ), Neisseria Gonorrhoeae Identification Kit (FDA Code:
JSX), ...
Culture Kits, Inc. is a distributor of diagnostic and medical products such as vacutainer, needles, syringes, rapid tests & other primary care products.
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FDA Code / Regulation: LGA / 866.2420 An oxidase screening test for gonorrhea is an in vitro device that consists of the articles intended to identify by chemical reaction, cytochrome oxidase, an oxidizing enzyme that is associated with certain bacteria includingNeisseria gonorrhoeae. A sample of a male's urethral discharge is obtained on a swab which is placed into a wetting agent containing an ingredient that will react with cytochrome oxidase. When cytochrome oxidase is present, the swab turns a dark purple color within 3 minutes. Because it is unlikely that cytochrome oxidase-positive organisms other thanNeisseria gonorrhoeae are present in the urethral discharge of males, the identification of cytochrome oxidase with this device indicates presumptive infection of the patient with the causative agent of gonorrhea.
Classification. Class III (premarket approval) (transitional device).