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ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL FDA UDI
Generic Name
Hepatitis B virus antigen/antibody marker IVD, control FDA UDI
Device Name
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL FDA UDI
Model / Reference
2000-0065 FDA UDI
Description
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00816784020925 FDA UDI
FDA Product Code
DGQ FDA UDI
GMDN Term
Hepatitis B virus antigen/antibody marker IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.5700 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

Yes

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, controlHepatitis B virus antigen/antibody marker IVD, control

ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Hepatitis B virus antigen/antibody marker IVD, control.

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 d57ec337-31c4-44c9-971d-a19699f97522 34 fields · synced Jun 9, 2026