Product code GNB— Microbiology
PHADEBACT SHIGELLA TEST
- Classification name
- Antisera, All Types, Shigella Spp.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3660
- Advisory panel
- Microbiology
- Total cleared
- 41
- First cleared
- Most recent
Market context for product code GNB
FDA has cleared devices under product code GNB between 1982 and 1996, filed by 4 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
- 1996
- 1995
- 1990
- 1989
- 1982
Top applicants under product code GNB
Recent clearances under product code GNB
- K961537 — SAS SHIGELLA SONNEI FORM II ANTISERUM
- K961528 — SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
- K961529 — SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
- K961531 — SAS SHIGELLA BOYDII TYPE 13 ANTISERUM
- K961532 — SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
- K961533 — SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
- K961534 — SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
- K961535 — SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM
- K961538 — SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
- K961539 — SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
- K961540 — SAS SHIGELLA SONNEI GROUP D ANTISERUM
- K961541 — SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
- K961542 — SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
- K961543 — SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
- K961546 — SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
- K961547 — SAS SHIGELLA BOYDII TYPE 14 ANTISERUM
- K961548 — SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
- K961549 — SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
- K961551 — SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
- K961553 — SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM
- K961554 — SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
- K961556 — SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
- K961558 — SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
- K961559 — SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
- K953316 — SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM
- K953317 — SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
- K953318 — SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM
- K953319 — SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
- K953320 — SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM
- K953321 — SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM
- K953322 — SAS SHIGELLA BOYDII TYPE 1 ANTISERUM
- K953323 — SAS SHIGELLA BOYDII TYPE 2 ANTISERUM
- K953324 — SAS SHIGELLA BOYDII TYPE 3 ANTISERUN
- K953325 — SAS SHIGELLA BOYDII TYPE 4 ANTISERUM
- K953326 — SAS SHIGELLA BOYDII TYPE 5 ANTISERUM
- K953327 — SAS SHIGELLA BOYDII TYPE 6 ANTISERUM
- K953328 — SAS SHIGELLA BOYDII TYPE 7 ANTISERUM
- K953329 — SAS SHIGELLA BOYDII GROUP C2 ANTISERUM
- K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC51
- K880752 — PHADEBACT SHIGELLA TEST
- K821337 — SHIGELLA I.D.
Data sourced from openFDA. This site is unofficial and independent of the FDA.