Identity
- Trade Name
- Chembio HIV 1/2 Stat-Pak Assay FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 60-9505-1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607158000052 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 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 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Chembio HIV 1/2 Stat-Pak Assay by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.
- OraQuick Advance Rapid HIV 1/2 Antibody Test — OraSure Technologies, Inc. · Class III
- INSTI HIV-1/HIV-2 Antibody Test — Biolytical Laboratories Inc · Class II
- OraQuick In Home HIV Test — OraSure Technologies, Inc. · Class II
- OraQuick In Home HIV Test, Pharmacy — OraSure Technologies, Inc. · Class II
- Geenius — Bio-Rad · Class II
- OraQuick In Home HIV Test (Not for Resale) — OraSure Technologies, Inc. · Class II
- Chembio HIV Reactive/Nonreactive Controls — Chembio Diagnostic Systems · Class II
- Chembio DPP HIV 1/2 Assay — Chembio Diagnostic Systems · Class II
Cleared under the same submission
BP050010 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chembio Diagnostic Systems
Sources (1)
- FDA UDI a6e480ce-31a3-4a52-9af3-0e0882e47c44 34 fields · synced Jun 6, 2026