Exact Diagnostics

FDA UDI

Class II (US FDA UDI)

by Exact Diagnostics

Identity

Trade Name: Exact Diagnostics FDA UDI
Generic Name: Hepatitis B virus nucleic acid IVD, calibrator FDA UDI
Device Name: HBV 1E6 IU/mL Precision FDA UDI
Model / Reference: HBVH202 FDA UDI
Description: HBV 1E6 IU/mL Precision FDA UDI

Identifiers

Catalog Number: HBVH202 FDA UDI
Primary DI / UDI-DI: 00812242030697 FDA UDI
FDA Product Code: JIT FDA UDI
GMDN Term: Hepatitis B virus nucleic acid IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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 nucleic acid IVD, calibrator

Exact Diagnostics by Exact Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatitis B virus nucleic acid IVD, calibrator.

Alinity m — Abbott Molecular · Class II
RealTime — Abbott Molecular · Class II
Aptima® — Hologic, Inc. · Class II
Exact Diagnostics — Exact Diagnostics · Class II
Exact Diagnostics — Exact Diagnostics · Class II
Exact Diagnostics — Exact Diagnostics · Class II
Exact Diagnostics — Exact Diagnostics · 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 II	Pending data

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Manufacturer

Manufacturer: Exact Diagnostics

Sources (1)

FDA UDI 3b65aee7-56a5-4ba7-b713-77e8af34f9ad 36 fields · synced Jun 9, 2026