AccessGUDID - DEVICE: DPP HIV-Syphilis (00607158000083)

GUDID

Device Identifier (DI) Information

Brand Name: DPP HIV-Syphilis
Version or Model: 65-9502-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chembio Diagnostic Systems Inc.

Primary DI Number: 00607158000083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 160348470 *Terms of Use

Device Description: The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.

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?
63667	HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) and Treponema pallidum, the bacteria associated with syphilis, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, Hiv Detection
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP180191	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: 3ff8d739-3adf-4deb-aab0-b6098755230f
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: December 29, 2020