Identity
- Trade Name
- Amplichek FDA UDI
- Generic Name
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI
- Device Name
- Amplichek I Level 2 (An assayed nucleic acid control.) FDA UDI
- Model / Reference
- 12000529 FDA UDI
- Description
- Amplichek I Level 2 (An assayed nucleic acid control.) FDA UDI
Identifiers
- Catalog Number
- 12000529 FDA UDI
- Primary DI / UDI-DI
- 03610520530078 FDA UDI
- 510(k) Number
- K152679 FDA UDI
- FDA Product Code
- PMN FDA UDI
- GMDN Term
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 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
No
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
No
FDA UDI
Category: HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control.
- cobas® HBV/HCV/HIV-1 Control Kit — Roche Diagnostics Corp. · Class II
- cobas® TaqScreen Cadaveric Specimen Diluent Kit — Roche Molecular Systems, Inc.
- cobas® HBV/HCV/HIV-1 Control Kit — Roche Molecular Systems, Inc. · Class II
- COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit — Roche Molecular Systems, Inc.
- cobas® TaqScreen MPX Control Kit — Roche Molecular Systems, Inc.
- cobas® TaqScreen MPX Control Kit, v2.0 — Roche Molecular Systems, Inc.
- cobas® MPX Control Kit — Roche Diagnostics Corp.
- Amplichek — Bio-Rad Laboratories · Class II
Cleared under the same submission
K152679 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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 44630c18-b546-4367-8b08-35e65b9c9c61 37 fields · synced Jun 8, 2026