Home › RANDOX LABORATORIES LIMITED › SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)

SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)

RANDOX LABORATORIES LIMITED · Model SR10346 · UDI-DI 05055273216394

MJX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.

Recalls

Date	Firm	Reason
2016-06-22	Ortho-Clinical Diagnostics	The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Contr

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 key Read 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.