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SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

RANDOX LABORATORIES LIMITED · Model SR10345 · UDI-DI 05055273216387

MJY Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
11
Facilities

Description

Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.

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

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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.