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COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit

FDA UDI

by Roche Molecular Systems, Inc.

Identity

Trade Name
COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit FDA UDI
Generic Name
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI
Model / Reference
03302555018 FDA UDI

Identifiers

Catalog Number
03302555018 FDA UDI
Primary DI / UDI-DI
00875197001051 FDA UDI
GMDN Term
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI

Classification

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

Yes

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: HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit by Roche Molecular Systems, Inc. — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as HIV1/Hepatitis C virus/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
Roche Molecular Systems, Inc.

Sources (1)

  • FDA UDI 13aefccc-252d-4cc0-899e-6681ce49c0bd 33 fields · synced Jun 9, 2026