Panels › Microbiology › Product code GNB · Class 2
Antisera, All Types, Shigella Spp.
Regulation 866.3660
0510(k)s in 12 months (41 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in GNB
| Company | 510(k)s | Recalls |
|---|---|---|
| Sa Scientific, Inc. | 38 | 0 |
| Becton Dickinson & Co. | 0 | 2 |
| Analytical Products, Inc. | 1 | 0 |
| Pharmacia, Inc. | 1 | 0 |
| Remel Inc | 0 | 1 |
| Wellcome Diagnostics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2017 | Remel Inc Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01.
Product Usage:
Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiol Terminated |
GNB | None listed |
| Aug 16, 2008 | Becton Dickinson & Co. Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017***
Used for the identification of Shigel Terminated |
GNB | None listed |
| Aug 16, 2008 | Becton Dickinson & Co. Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antiserum Set", Cat. 241108, Lot 6073806). Via Terminated |
GNB | None listed |
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