Whole Human Serum, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5700
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
17 firms currently registered for this product code
Immco Diagnostics, Inc.
Williamsville, NY, US
Theradiag
MARNE LA VALLEE CEDEX 2 Seine-et-Marne, FR
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho Clinical Diagnostics
Singapore South West, SG
Isomedix Operations, Inc.
Libertyville, IL, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Glycominds Diagnostics (2014) Ltd.
Raanana Central, IL
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Labotek Group Corp
Bayamon, PR, US
Kent Laboratories, Inc.
BELLINGHAM, WA, US
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Agilent Technologies Denmark Aps
GLOSTRUP Hovedstaden, DK
Agilent Technologies Inc.
Cedar Creek, TX, US
Savyon Diagnostics Ltd.
ASHDOD Southern, IL
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Hemo Bioscience
Durham, NC, US
510(k) clearances
5 clearances for this product code
- Consolidated Technologies, Inc.Sep 24, 1996
K961544 · QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
- Boehringer Mannheim Corp.Sep 5, 1990
K902220 · PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
- Bio-RadJan 9, 1987
K865014 · LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
- Kallestad Laboratories, Inc.Apr 4, 1979
K790298 · RADIOASSAY, CONTROL SERUM I, II, III
- Beckman Instruments, Inc.Aug 31, 1978
K781355 · ICS NORMAL CONTROL SERUM