Access Bio Incorporate
Country not established
- Devices
- 4
What Access Bio Incorporate makes
Access Bio Incorporated manufactures rapid diagnostic tests for pregnancy and cardiac markers, including urine-based hCG pregnancy tests and blood-based troponin I, CK-MB, and myoglobin assays. The company also produces combo tests combining hCG pregnancy detection with additional diagnostic markers.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Carestart Hcg One-Step Pregnancy Test Ref K031052
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Carestart-Pregnancy And Carestart Plus-Pregnancy Ref K032159
Regimes: 510(k) Registry: 510(k)Carestart Hcg Combo One-Step Pregnancy Test And Carestart Plus Hcg Combo One-Step Pregnancy Test Ref K031048
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Access Bio Incorporate have in the registry?
The registry currently lists 4 devices for Access Bio Incorporate. Devices recorded under merged duplicate company entries are counted once.
Which registries list Access Bio Incorporate's devices?
Among its 4 most recently registered devices, Access Bio Incorporate has devices listed in FDA 510(k) (4 devices).
What risk classes do Access Bio Incorporate's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Access Bio Incorporate's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Access Bio Incorporate in the registry?
The most recently registered devices listed for Access Bio Incorporate include CARESTART HCG ONE-STEP PREGNANCY TEST, CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN, CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY and CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST.