PreciControl HBsAg II

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: PreciControl HBsAg II FDA UDI
Generic Name: Hepatitis B virus surface antigen IVD, control FDA UDI
Model / Reference: 04687876160 FDA UDI

Identifiers

Catalog Number: 04687876160 FDA UDI
Primary DI / UDI-DI: 07613336106402 FDA UDI
PMA Number: P160019 FDA UDI
FDA Product Code: LOM FDA UDI
GMDN Term: Hepatitis B virus surface antigen IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3172 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Hepatitis B virus surface antigen IVD, control

PreciControl HBsAg II by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Hepatitis B virus surface antigen IVD, control.

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Alinity — Abbott Ireland Diagnostics
LIAISON XL MUREX Control HBsAg Qual — Diasorin S.P.A
ARCHITECT — Abbott Ireland Diagnostics · Class II
ADVIA Centaur® Systems HBsAg QC — Siemens Healthcare Diagnostics · Class II
Atellica™ IM HBsII QC — Siemens Healthcare Diagnostics · Class II
Hepatitis B Virus Surface Antigen Control Slides — BIO SB, INC. · Class I

Cleared under the same submission

P160019 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI af81f909-335e-4e6f-8b3b-2e2e4d20f67f 35 fields · synced May 31, 2026