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Media, Potentiating For In Vitro Diagnostic Use
FDA product code KSG · Class 2 · Hematology
23
Registered devices
11
Adverse events
1
Recalls
13
510(k) clearances
Devices with this code
ORTHO — ORTHO-CLINICAL DIAGNOSTICS, INC.PEG — American National Red CrossBovine Serum Albumin 22% — ALBA BIOSCIENCE LIMITEDLISS — American National Red CrossGamma EGA Kit — IMMUCOR, INC.MTS — MICRO TYPING SYSTEMS, INCGamma PeG — IMMUCOR, INC.Bovine Albumin Solution 22% — IMMUCOR, INC.IH-LISS Solution — Bio-Rad Medical Diagnostics GmbHLISS — DIAGASTORTHO — ORTHO-CLINICAL DIAGNOSTICS, INC.MTS — MICRO TYPING SYSTEMS, INCGamma ELU-KIT II — IMMUCOR, INC.Gamma LO-ION — IMMUCOR, INC.IH-Titration Rack — Bio-Rad Medical Diagnostics GmbHGamma N-HANCE — IMMUCOR, INC.ImmuAdd — IMMUCOR, INC.IH-LISS Rack — Bio-Rad Medical Diagnostics GmbHIH-Titration Solution — Bio-Rad Medical Diagnostics GmbHELUclear — HEMO BIOSCIENCE INCGamma N-HANCE — IMMUCOR, INC.ALBAhance PEG — ALBA BIOSCIENCE LIMITEDGamma PeG — IMMUCOR, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-14 | Ortho Clinical Diagnostics Inc | Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored |
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