GNB · Class II · 21 CFR 866.3660

FDA Product Code GNB: Antisera, All Types, Shigella Spp.

Leading manufacturers include Sa Scientific, Inc., Analytical Products, Inc. and Pharmacia, Inc..

41
Total
41
Cleared
36d
Avg days
1982
Since

FDA 510(k) Cleared Antisera, All Types, Shigella Spp. Devices (Product Code GNB)

41 devices
1–24 of 41
Cleared May 31, 1996
SAS SHIGELLA SONNEI FORM II ANTISERUM
K961537
Sa Scientific, Inc.
Microbiology · 39d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
K961528
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
K961529
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM
K961531
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
K961532
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
K961533
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
K961534
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM
K961535
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
K961538
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
K961539
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA SONNEI GROUP D ANTISERUM
K961540
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
K961541
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
K961542
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
K961543
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
K961546
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM
K961547
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
K961548
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
K961549
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
K961551
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM
K961553
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
K961554
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
K961556
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
K961558
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
K961559
Sa Scientific, Inc.
Microbiology · 28d

About Product Code GNB - Regulatory Context