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Accurun®

FDA UDI

Class II (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
ACCURUN® FDA UDI
Generic Name
Multiple blood-borne virus antigen/antibody IVD, control FDA UDI
Device Name
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL FDA UDI
Model / Reference
2000-0032 FDA UDI
Description
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL FDA UDI

Identifiers

Catalog Number
2000-0032 FDA UDI
Primary DI / UDI-DI
00816784020123 FDA UDI
FDA Product Code
KSF FDA UDI
GMDN Term
Multiple blood-borne virus antigen/antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Multiple blood-borne virus antigen/antibody IVD, control

Accurun® by LGC Clinical Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood-borne virus antigen/antibody IVD, control.

Cleared under the same submission

BK930027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LGC Clinical Diagnostics, Inc.

Sources (1)

  • FDA UDI f9cc8d95-c74a-4cf6-af89-9b6dc5ea29bd 36 fields · synced Jun 9, 2026