GMP

Antisera, Control For Nontreponemal Tests

Product code
GMP
Device name
Antisera, Control For Nontreponemal Tests
Device class
Class 2
21 CFR
21 CFR 866.3820
Medical specialty
Microbiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)
Official FDA classification page: GMP
Classification and pathway per current FDA publications. Data from openFDA (CC0).