PreciControl HIV +1 more model

FDA UDI

Class U (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: PreciControl HIV; HIV-2+GrpO FDA UDI
Generic Name: HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Model / Reference: 06924115162 FDA UDI

Identifiers

Catalog Number: 06924115162 FDA UDI
Primary DI / UDI-DI: 07613336183229 FDA UDI
FDA Product Code: QHM FDA UDI
GMDN Term: HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Models / Variants: PreciControl HIV FDA UDI
HIV-2+GrpO FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 610.40 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: HIV1/HIV2 antigen/antibody IVD, control

PreciControl HIV +1 more model by Roche Diagnostics Corp. — Class U — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

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Alinity — Abbott · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI 8f9f8853-8a68-43b2-a81c-ba8e7cf0cb83 33 fields · synced May 30, 2026