Home › DRG Instruments Gesellschaft mit beschränkter Haftung › ENA-6-Profile ELISA
ENA-6-Profile ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3901 · UDI-DI 04048474039016
LLL
Prescription
1
510(k) clearances
1
Adverse events
4
Recalls
24
Facilities
Description
The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class antibodies against Schistosoma mansoni in human serum or plasma (citrate, heparin).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-08-06 | Diamedix Corporation | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
| 2011-06-08 | Diamedix Corporation | On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an e |
| 2008-11-25 | Immuno Concepts Inc | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. |
| 2004-04-20 | Diasorin Inc. | An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing. |
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 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.