FDA Device Intelligence
Home › BIO-RAD LABORATORIES, INC. › BioPlex 2200

BioPlex 2200

BIO-RAD LABORATORIES, INC. · Model SW4_V3 · UDI-DI 00847865002240

OMI
2
510(k) clearances
24
Adverse events
1
Recalls
2
Facilities

Description

ToRC IgG Assay Protocol File CD, SW 4_v3

Recalls

DateFirmReason
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).

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.