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Serology Lyme Disease Posititve Control (lyme Control +)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref SR10346

by Randox Laboratories Limited

Identity

Trade Name
SEROLOGY LYME DISEASE POSITITVE CONTROL (LYME CONTROL +) EUDAMED
SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +) FDA UDI
Generic Name
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI
Device Name
SEROLOGY LYME DISEASE CONTROL EUDAMED
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. FDA UDI
Model / Reference
SR10346 EUDAMEDFDA UDI
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. FDA UDI

Identifiers

Catalog Number
SR10346 FDA UDI
Primary DI / UDI-DI
05055273216394 EUDAMEDFDA UDI
Basic UDI-DI
50552732BSELYDC124N4 EUDAMED
FDA Product Code
MJX FDA UDI
EMDN Code
W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
GMDN Term
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Serology Lyme Disease Posititve Control (lyme Control +) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED 4343c47f-8b4a-416e-8c9d-4c25026c1213 61 fields · synced Jul 31, 2026
  • FDA UDI 271c9611-9d05-4bc5-9e0d-c2866cda1510 36 fields · synced May 30, 2026