Home › Device types › GSY
Antisera, Fluorescent, All Globulins, Proteus Spp.
FDA product code GSY · Class 1 · Microbiology
7
Registered devices
0
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
PROTEUS OX19 ANTIGEN — GERMAINE LABORATORIES, INCProteus OX19 Agglutinating Serum — REMEL EUROPE LIMITEDProteus OX2 Agglutinating Serum — REMEL EUROPE LIMITEDPROTEUS POLY ANTISERUM — GERMAINE LABORATORIES, INCPROTEUS OX2 ANTIGEN — GERMAINE LABORATORIES, INCPROTEUS OXK ANTIGEN — GERMAINE LABORATORIES, INCProteus OXK Agglutinating Serum — REMEL EUROPE LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
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