FDA Device Intelligence
HomeBiobase Biodustry(Shandong)Co., Ltd. › BIOBASE

BIOBASE

Biobase Biodustry(Shandong)Co., Ltd. · Model Calibrator: 1mL×1 · UDI-DI 06971674867906

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

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.