Biotek Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Biotek Solutions, Inc. makes
Biotek Solutions, Inc. manufactures immunohistochemical (IHC) staining kits, including CHEMMATE™ LAMBDA, CD20 (L26), CD43, LCA-CD45, CD45-RO (UCHL1), and kappa light chain detection reagents. These products are designed for use in pathology laboratories to identify and differentiate cellular markers in tissue samples, aiding in diagnostic processes such as cancer detection and classification.
The company’s portfolio is regulated under FDA Class II devices and is supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Biotek Solutions, Inc. is headquartered in the United States.
Catalogue
Chemmate(Tm) Lambda Ref K950149
Regimes: 510(k) Registry: 510(k)Chemmate(Tm) L26 (CD20) Ref K950151
Regimes: 510(k) Registry: 510(k)Chemmate(Tm) CD43 Ref K950148
Regimes: 510(k) Registry: 510(k)Chemmate Special Stain Lca-CD45 Ref K936111
Regimes: 510(k) Registry: 510(k)Chemmate(Tm) UCHL1 (CD45-Ro) Ref K950152
Regimes: 510(k) Registry: 510(k)Chemmate(Tm) Kappa Ref K950150
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotek Solutions, Inc. have in the registry?
The registry currently lists 6 devices for Biotek Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotek Solutions, Inc.'s devices?
Among its 6 most recently registered devices, Biotek Solutions, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biotek Solutions, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biotek Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotek Solutions, Inc. in the registry?
The most recently registered devices listed for Biotek Solutions, Inc. include CHEMMATE(TM) LAMBDA, CHEMMATE(TM) L26 (CD20), CHEMMATE(TM) CD43 and CHEMMATE SPECIAL STAIN LCA-CD45.