Good Biotech Corp.
Country not established
- Devices
- 8
What Good Biotech Corp. makes
Good Biotech Corp. manufactures lateral flow immunoassays (LIA) and turbidimetric immunoassays (TIA) for laboratory testing, including C-reactive protein (CRP) assays, high-sensitivity CRP (hs-CRP) assays, transferrin, microalbumin, and ferritin tests. Their products include assay kits, calibrator sets, and multi-level controls for quantitative and qualitative diagnostic measurements.
The company’s portfolio is regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Their assays are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Duet Hs-Crp Lit Assay, Catalog Number: 4010, Duet Hs-Crp Calibrator Set, Catalog Number: 4511 Ref K050713
Regimes: 510(k) Registry: 510(k)Crpex-Hs Crp Calibrator Set, Catalog No: 1510 Ref K021882
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Transferrin Tia, Calibrator Set, Control-L, Control-M, Control-H, Model# Kt-0105-A, Ca-0105-A, B, C Ref K063766
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Good Biotech Corp. have in the registry?
The registry currently lists 8 devices for Good Biotech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Good Biotech Corp.'s devices?
Among its 8 most recently registered devices, Good Biotech Corp. has devices listed in FDA 510(k) (8 devices).
What risk classes do Good Biotech Corp.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Good Biotech Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Good Biotech Corp. in the registry?
The most recently registered devices listed for Good Biotech Corp. include CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET, DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511, CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 and CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013.