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DPP HIV-Syphilis

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name
DPP HIV-Syphilis FDA UDI
Generic Name
HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical FDA UDI
Device Name
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. FDA UDI
Model / Reference
65-9502-0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00607158000083 FDA UDI
FDA Product Code
MZF FDA UDI
LIP FDA UDI
GMDN Term
HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3956 FDA UDI
866.3830 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical

DPP HIV-Syphilis by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chembio Diagnostic Systems

Sources (1)

  • FDA UDI 3ff8d739-3adf-4deb-aab0-b6098755230f 34 fields · synced Jun 1, 2026