Product code GNC— Microbiology
AGGLUTINOTEST-SALMONELLA
- Classification name
- Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3550
- Advisory panel
- Microbiology
- Total cleared
- 60
- First cleared
- Most recent
Market context for product code GNC
FDA has cleared devices under product code GNC between 1979 and 1997, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1996
- 1995
- 1988
- 1980
- 1979
Top applicants under product code GNC
Recent clearances under product code GNC
- K972386 — VISTA ANTIGEN SALMONELLA O GROUP B
- K972387 — VISTA ANTIGEN SALMONELLA O GROUP A
- K972388 — VISTA ANTIGEN SALMONELLA O GROUP C
- K972389 — VISTA ANTIGEN SALMONELLA H D
- K972390 — VISTA ANTIGEN SALMONELLA H C
- K972391 — VISTA ANTIGEN SALMONELLA H B
- K972392 — VISTA ANTIGEN SALMONELLA H A
- K972395 — VISTA ANTIGEN SALMONELLA O GROUP D
- K955223 — SAS SPICER-EDWARDS 1 ANTISERUM
- K955224 — SAS SPICER-EDWARDS 2 ANTISERUM
- K955225 — SAS SPICER-EDWARDS 3 ANTISERUM
- K955226 — SAS SPICER-EDWARDS 4 ANTISERUM
- K955227 — SAS SPICER-EDWARDS EN COMPLEX ANTISERUM
- K955228 — SAS SPICER-EDWARDS L COMPLEX
- K955195 — SAL SALMONELLA H Q ANTISERUM
- K955196 — SAS SALMONELLA H POLY E ANTISERUM
- K955197 — SAS SALMONELLA H POLY D ANTISERUM
- K955211 — SAS SALMONELLA H FACTOR 6 ANTISERUM
- K955212 — SAS SALMONELLA H FACTOR 5 ANTISERUM
- K955213 — SAS SALMONELLA H E,N,Z15 ANTISERUM
- K955214 — SAS SALMONELLA E,N,X ANTISERUM
- K955215 — SAS SALMONELLA H E COMPLEX ANTISERUM
- K955216 — SAS SALMONELLA H A ANTISERUM
- K955217 — SAS SALMONELLA H 1,2 ANTISERUM
- K955218 — SAS SALMONELLA H 1,7 ANTISERUM
- K955219 — SAS SALMONELLA H FACTOR 7 ANTISERUM
- K955220 — SAS SALMONELLA H Z36 ANTISERUM
- K955221 — SAS SALMONELLA H Z38 ANTISERUM
- K955186 — SAS SALMONELLA H Z29 ANTISERUM
- K955187 — SAS SALMONELLA H Z4, Z23 ANTISERUM
- K955188 — SAS SALMONELLA H Z6 ANTISERUM
- K955189 — SAS SALMONELLA H Z ANTISERUM
- K955190 — SAS SALMONELLA H Y ANTISERUM
- K955191 — SAS SALMONELLA H X ANTISERUM
- K955192 — SAS SALMONELLA H T ANTISERUM
- K955193 — SAS SALMONELLA H S ANTISERUM
- K955194 — SAS SALMONELLA H R ANTISERUM
- K955198 — SAS SALMONELLA H POLY C ANTISERUM
- K955199 — SAS SALMONELLA H POLY B ANTISERUM
- K955200 — SAS SALMONELLA H POLY A ANTISERUM
- K955201 — SAS SALMONELLA H,M,T, ANTISERUM
- K955202 — SAS SALMONELLA H L,Z40 ANTISERUM
- K955203 — SAS SALMONELLA H L,Z13 ANTISERUM
- K955204 — SAS SALMONELLA H L,W ANTISERUM
- K955205 — SAS SALMONELLA H L,V ANTISERUM
- K955206 — SAS SALMONELLA H K ANTISERUM
- K955207 — SAS SALMONELLA H I ANTISERUM
- K955208 — SAS SALMONELLA H H ANTISERUM
- K955209 — SAS SALMONELLA H G,M ANTISERUM
- K955210 — SAS SALMONELLA H F,G, ANTISERUM
- K953841 — SAS SALMONELLA O GROUP A ANTIGEN
- K953842 — SAS SALMONELLA H C ANTIGEN
- K953843 — SAS SALMONELLA O GROUP F ANTIGEN
- K953844 — SAS SALMONELLA VI ANTIGEN
- K953846 — SAS SALMONELLA O GROUP C ANTIGEN
- K953848 — SAS SALMONELLA O GROUP B ANTIGEN
- K952142 — SAS SALMONELLA O GROUP D ANTIGEN
- K883685 — IMMUNO/FEBRILE ANTIGENS
- K801693 — SALMONELLA FLAGELLAR A ANTIGEN & B
- K791450 — AGGLUTINOTEST-SALMONELLA
Data sourced from openFDA. This site is unofficial and independent of the FDA.