Igm (mu Chain Specific), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550
Recent MDR events
18 adverse event reports on file
- TINA-QUANT IGM GEN.2Jul 10, 2026MalfunctionRoche Diagnostics1823260-2026-02799
- TINA-QUANT IGM GEN.2Jun 23, 2026MalfunctionRoche Diagnostics1823260-2026-02478
- TINA-QUANT IGM GEN.2Feb 23, 2026MalfunctionRoche Diagnostics1823260-2026-00635
- TINA-QUANT IGM GEN.2Jun 27, 2025MalfunctionRoche Diagnostics1823260-2025-01966
- TINA-QUANT IGM GEN.2Jun 13, 2025MalfunctionRoche Diagnostics1823260-2025-01818
- TINA-QUANT IGM GEN.2Apr 7, 2025MalfunctionRoche Diagnostics1823260-2025-01025
- TINA-QUANT IGM GEN.2Mar 3, 2025MalfunctionRoche Diagnostics1823260-2025-00598
- ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Aug 21, 2024MalfunctionRoche Diagnostics1823260-2024-02425
- TINA-QUANT IGM GEN.2Jul 22, 2024MalfunctionRoche Diagnostics1823260-2024-02112
- ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Feb 15, 2024MalfunctionRoche Diagnostics1823260-2024-00452
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Agilent Technologies Inc.
Cedar Creek, TX, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Diamond Diagnostics Inc.
Budapest, HU
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
Kent Laboratories, Inc.
BELLINGHAM, WA, US
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
510(k) clearances
8 clearances for this product code
- Roche Diagnostics Corp.Mar 10, 2004
K040431 · ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
- Helena LaboratoriesNov 4, 1998
K982639 · SPIFE URINE IFE
- Boehringer Mannheim Corp.Feb 9, 1996
K955908 · BOEHRINGER MANNHEIM IGM ASSAY
- Applications LabMar 14, 1985
K850586 · SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
- Advanced Cardiovascular Systems, Inc.Jun 11, 1984
K841992 · MODIFICATION TO ACS CORONARY GUIDING
- Dako Corp.Sep 23, 1981
K812487 · IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
- Electro-Nucleonics Laboratories, Inc.Apr 24, 1980
K800450 · GEMENI IGM ASSAY
- Kent Laboratories, Inc.Apr 12, 1979
K790705 · ANTISERUM TO HUMAN IGM