AccessGUDID - DEVICE: Chembio HIV 1/2 Stat-Pak Assay (00607158000052)

GUDID

Device Identifier (DI) Information

Brand Name: Chembio HIV 1/2 Stat-Pak Assay
Version or Model: 60-9505-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chembio Diagnostic Systems Inc.

Primary DI Number: 00607158000052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 160348470 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48454	HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, Hiv Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP050010	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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