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ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000

EUDAMEDFDA UDI

Class IVD Annex II List B (EU MDR)

Ref 2000-0039

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 EUDAMED
ACCURUN® FDA UDI
Generic Name
Mumps virus immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 EUDAMED
ACCURUN 40 Series 5000 Anti- Measles, Mumps, Rubella, VZV 3 x 1.0 mL FDA UDI
Model / Reference
2000-0039 EUDAMEDFDA UDI
Description
ACCURUN 40 Series 5000 Anti- Measles, Mumps, Rubella, VZV 3 x 1.0 mL FDA UDI

Identifiers

Catalog Number
2000-0039 FDA UDI
Primary DI / UDI-DI
00816784020178 EUDAMEDFDA UDI
Basic UDI-DI
B-00816784020178 EUDAMED
FDA Product Code
DGQ FDA UDI
EMDN Code
W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
GMDN Term
Mumps virus immunoglobulin G (IgG) antibody IVD, control FDA UDI

Classification

Device Class
Class IVD Annex II List B EUDAMED
Class I FDA UDI
Regulation Number
866.5700 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000 by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — IVDD, FDA UDI…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LGC Clinical Diagnostics, Inc.
EUDAMED SRN
US-MF-000016356
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (2)

  • EUDAMED f3be58ad-a114-4528-bbd0-e29d508eaf5c 61 fields · synced Jun 19, 2026
  • FDA UDI 1fc31d79-cd62-43ab-becf-010e4751e1ad 35 fields · synced May 30, 2026