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AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit

FDA UDI

Class I (US FDA UDI)

by LGC Clinical Diagnostics, Inc.

Identity

Trade Name
AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit FDA UDI
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Device Name
AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit FDA UDI
Model / Reference
0505-0260 FDA UDI
Description
AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00860006589714 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple-genus respiratory 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

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-genus respiratory virus nucleic acid IVD, control

AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple-genus respiratory 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 d7d6d20d-9b23-4caa-890c-0f05a59a1a47 33 fields · synced Jun 9, 2026