Amf Biological and Diagnostics Co.
Country not established
- Devices
- 5
What Amf Biological and Diagnostics Co. makes
Amf Biological and Diagnostics manufactures diagnostic kits for hormone and antibody testing, including ZETA-SERA D for serum diagnostics, ZETA-CORT for cortisol measurement, and QCM-SP1/SP2 for abnormal concentration detection. The Zetaphase T4 and T3 diagnostic kits assess thyroid function via radioimmunoassay methods.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s offerings are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Zeta-Sera D Ref K812329
Regimes: 510(k) Registry: 510(k)Zeta-Cort Ref K821931
Regimes: 510(k) Registry: 510(k)Qcm-SP1(Normal Concenttration) & SP2(Abnormal) Ref K852418
Regimes: 510(k) Registry: 510(k)Zetaphase T4 Radioimmunoassay Diag. Kit Ref K821554
Regimes: 510(k) Registry: 510(k)Zetaphase T3 Uptake Diagnostic Kit Ref K821553
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amf Biological and Diagnostics Co. have in the registry?
The registry currently lists 5 devices for Amf Biological and Diagnostics Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amf Biological and Diagnostics Co.'s devices?
Among its 5 most recently registered devices, Amf Biological and Diagnostics Co. has devices listed in FDA 510(k) (5 devices).
What risk classes do Amf Biological and Diagnostics Co.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Amf Biological and Diagnostics Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amf Biological and Diagnostics Co. in the registry?
The most recently registered devices listed for Amf Biological and Diagnostics Co. include ZETA-SERA D, ZETA-CORT, QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) and ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT.