Biopool Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Biopool Intl., Inc. makes
Biopool Intl., Inc. makes medical devices such as the FETAL D TECTION KIT, I-STAT COAGULATION CONTROL SET, BIOCLOT APC SENSITIVITY, and MINIQUANT D-DIMER, which are used for various diagnostic purposes.
The company's portfolio is classified as Class II devices and is listed in the FDA 510(k) registry, with the company being based in the US.
Catalogue
Fetal D Tection Kit Ref K980314
Regimes: 510(k) Registry: 510(k)I-Stat Coagulation Control Set Ref K981752
Regimes: 510(k) Registry: 510(k)Bioclot Apc Sensitivity Ref K983898
Regimes: 510(k) Registry: 510(k)Miniquant D-Dimer, Model 1447 Ref K002642
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biopool Intl., Inc. have in the registry?
The registry currently lists 4 devices for Biopool Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biopool Intl., Inc.'s devices?
Among its 4 most recently registered devices, Biopool Intl., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Biopool Intl., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biopool Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biopool Intl., Inc. in the registry?
The most recently registered devices listed for Biopool Intl., Inc. include FETAL D TECTION KIT, I-STAT COAGULATION CONTROL SET, BIOCLOT APC SENSITIVITY and MINIQUANT D-DIMER, MODEL 1447.