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SpermMar IgG Negative Control

Fertipro NV · Model SPMG_N · UDI-DI 05411967001361

KTO
2
510(k) clearances
5
Adverse events
2
Recalls
5
Facilities

Description

SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website: www.fertipro.com

Recalls

DateFirmReason
2014-12-22Vitrolife IncThe firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when th
2003-05-07Ventana Medical Systems IncKit does not stain tissues properly.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.