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ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 2020-0105Model 2020-0105

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 EUDAMED
ACCURUN® FDA UDI
Generic Name
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI
Device Name
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 EUDAMED
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL FDA UDI
Model / Reference
2020-0105 EUDAMEDFDA UDI
Description
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL FDA UDI

Identifiers

Catalog Number
2020-0105 FDA UDI
Primary DI / UDI-DI
00816784020628 EUDAMEDFDA UDI
Basic UDI-DI
B-00816784020628 EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
GMDN Term
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1660 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 20 Milliliter FDA UDI

ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in…

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 044497b9-8a76-4abe-84db-3d96e63318b6 61 fields · synced Oct 6, 2026
  • FDA UDI 46948797-19fe-4790-9503-b7c272a1602b 37 fields · synced May 30, 2026