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Accurun®

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
ACCURUN® FDA UDI
Generic Name
Hepatitis B virus nucleic acid IVD, control FDA UDI
Device Name
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL FDA UDI
Model / Reference
2020-0095 FDA UDI
Description
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL FDA UDI

Identifiers

Catalog Number
2020-0095 FDA UDI
Primary DI / UDI-DI
00816784020581 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Hepatitis B virus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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: Hepatitis B virus nucleic acid IVD, control

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

Similar devices

Also classified as Hepatitis B virus nucleic acid 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 40a27108-dfc8-4eb0-922d-81ff7ab1f17b 36 fields · synced Jun 9, 2026