Product Code: GNB
FDA class 2
21 CFR 866.3660
Antisera, All Types, Shigella Spp.
Microbiology
The Antisera for All Types of Shigella Species are serotyping reagents used in microbiology laboratories to identify and classify Shigella isolates responsible for bacterial dysentery (shigellosis), a significant cause of diarrheal disease worldwide. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GNB, regulated under 21 CFR 866.3660 in the Microbiology specialty.
510(k)s
41
FEI Numbers
9
Registration Numbers
9
Unique Applicants
4
Years Active
14
Basic Information
- Product Code
- GNB
- Device Class
- FDA class 2
- Regulation Number
- 866.3660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 41 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | May 31, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961531 | SAS SHIGELLA BOYDII TYPE 13 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961529 | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K961528 | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | May 20, 1996 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953321 | SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953320 | SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953319 | SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953318 | SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953317 | SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953316 | SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM | Aug 04, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953329 | SAS SHIGELLA BOYDII GROUP C2 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953328 | SAS SHIGELLA BOYDII TYPE 7 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953327 | SAS SHIGELLA BOYDII TYPE 6 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953326 | SAS SHIGELLA BOYDII TYPE 5 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953325 | SAS SHIGELLA BOYDII TYPE 4 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953324 | SAS SHIGELLA BOYDII TYPE 3 ANTISERUN | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953323 | SAS SHIGELLA BOYDII TYPE 2 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K953322 | SAS SHIGELLA BOYDII TYPE 1 ANTISERUM | Aug 02, 1995 | Substantially Equivalent | SA SCIENTIFIC, INC. |
| K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 | Jan 11, 1990 | Substantially Equivalent | WELLCOME DIAGNOSTICS |
| K880752 | PHADEBACT SHIGELLA TEST | Feb 17, 1989 | Substantially Equivalent | PHARMACIA, INC. |
| K821337 | SHIGELLA I.D. | May 28, 1982 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.