Home › HYCOR BIOMEDICAL LLC › Autostat II Anti-Sm/RNP
Autostat II Anti-Sm/RNP
HYCOR BIOMEDICAL LLC · Model FGA32 · UDI-DI 00816879020328
10
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
96 well ELISA for the detection of Anti-Sm/RNP antibodies in human serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-10-21 | Euro Diagnostica AB | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
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Get your free API keyRead the docsData 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.
