Atlas FDA

GNB

41 FDA 510(k) clearances · Product code

28 daysmedian time to decision
28 days90th percentile
41clearances measured

FDA profile

Official device name
Antisera, All Types, Shigella Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3660
Medical specialty
Microbiology
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RecordFirmDate
SAS SHIGELLA SONNEI FORM II ANTISERUM (K961537)Sa Scientific, Inc.1996-05-31
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) (K961528)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (K961551)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM (K961532)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (K961546)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM (K961529)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM (K961535)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (K961534)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM (K961549)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM (K961538)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM (K961554)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM (K961548)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM (K961543)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM (K961553)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM (K961558)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM (K961539)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM (K961547)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM (K961531)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM (K961541)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM (K961533)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM (K961559)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA SONNEI GROUP D ANTISERUM (K961540)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM (K961556)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM (K961542)Sa Scientific, Inc.1996-05-20
SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM (K953320)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM (K953319)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM (K953316)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM (K953318)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM (K953317)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM (K953321)Sa Scientific, Inc.1995-08-04
SAS SHIGELLA BOYDII TYPE 2 ANTISERUM (K953323)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM (K953327)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM (K953326)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM (K953328)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 1 ANTISERUM (K953322)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM (K953329)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 4 ANTISERUM (K953325)Sa Scientific, Inc.1995-08-02
SAS SHIGELLA BOYDII TYPE 3 ANTISERUN (K953324)Sa Scientific, Inc.1995-08-02
WELLCOLEX COLOUR SHIGELLA TEST ZC51 (K895461)Wellcome Diagnostics1990-01-11
PHADEBACT SHIGELLA TEST (K880752)Pharmacia, Inc.1989-02-17
SHIGELLA I.D. (K821337)Analytical Products, Inc.1982-05-28

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