Chembio SURE CHECK HIV 1/2 Assay - The Chembio SURE CHECK® HIV 1/2 Assay is a - Chembio Diagnostic Systems Inc.

Duns Number:160348470

Device Description: The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the d The Chembio SURE CHECK® 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 Chembio SURE CHECK® 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 each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice.

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More Product Details

Catalog Number

-

Brand Name

Chembio SURE CHECK HIV 1/2 Assay

Version/Model Number

60-9507-0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BP050009,BP050009

Product Code Details

Product Code

MZF

Product Code Name

Test, Hiv Detection

Device Record Status

Public Device Record Key

607a3ed4-8208-48a5-bd87-7ea8581a7467

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHEMBIO DIAGNOSTIC SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 9