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Haemophilus influenza B IgG ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2530 · UDI-DI 04048474025309

GRP Prescription
6
510(k) clearances
11
Adverse events
1
Recalls
6
Facilities

Description

Enzyme immunoassay for the determination of IgG antibodies against polyribosylribitolphosphate (PRP) of Haemophilus influenzae type B in human serum and plasma.

Recalls

DateFirmReason
2018-08-12The Binding Site Group, Ltd.A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affect

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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.