Clearview Complete HIV 1/2

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name: Clearview Complete HIV 1/2 FDA UDI
Generic Name: HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
Device Name: The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice. FDA UDI
Model / Reference: 60-9523-0 FDA UDI
Description: The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice. FDA UDI

Identifiers

Primary DI / UDI-DI: 00607158000021 FDA UDI
FDA Product Code: MZF FDA UDI
GMDN Term: HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3956 FDA UDI
Commercial Distribution: Not 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

Yes

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

Yes

FDA UDI

Clearview Complete HIV 1/2 by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BP050009 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Chembio Diagnostic Systems

Sources (1)

FDA UDI 229251fe-5d92-4175-86fd-156b72ee427d 35 fields · synced Jun 8, 2026