Armkel, LLC
United StatesFDA applicant, unverified
- Devices
- 68
What Armkel, LLC makes
Armkel, LLC manufactures rapid diagnostic tests for infectious diseases, including a test for *Influenzae Type B* and *Group B Streptococcus*, as well as pregnancy tests under various brand names such as *First Response* and *Answer*. The company also produces condoms with natural and latex materials, including lubricated and spermicidal variants. Additionally, it supplies reference preparations for rheumatoid factor testing and related diagnostic reagents.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with most cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Search and filter all 68 devicesShowing 1-50 of 68
Frequently asked questions
How many devices does Armkel, LLC have in the registry?
The registry currently lists 68 devices for Armkel, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Armkel, LLC's devices?
Among its 50 most recently registered devices, Armkel, LLC has devices listed in FDA 510(k) (50 devices).
What risk classes do Armkel, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Armkel, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Armkel, LLC in the registry?
The most recently registered devices listed for Armkel, LLC include POSITIVE & NEGATIVE HCG URINE CONTROLS, BACTOGEN-H. INFLUENZAE TYPE B, BACTIGEN(R) GROUP B STREPTOCOCCUS TEST and TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM..