Chembio HIV 1/2 Stat-Pak Assay - The Chembio HIV 1/2 STAT-PAK® Assay is a - Chembio Diagnostic Systems Inc.

Duns Number:160348470

Device Description: The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the det The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® 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 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.

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More Product Details

Catalog Number

-

Brand Name

Chembio HIV 1/2 Stat-Pak Assay

Version/Model Number

60-9505-1

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

BP050010

Product Code Details

Product Code

MZF

Product Code Name

Test, Hiv Detection

Device Record Status

Public Device Record Key

a6e480ce-31a3-4a52-9af3-0e0882e47c44

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2014

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