Identity
- Trade Name
- AmpliClear FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
- Device Name
- AmpliClear (An unassayed C. trachomatis and N. gonorrhoeae nucleic acid control.) FDA UDI
- Model / Reference
- 00127 FDA UDI
- Description
- AmpliClear (An unassayed C. trachomatis and N. gonorrhoeae nucleic acid control.) FDA UDI
Identifiers
- Catalog Number
- 00127 FDA UDI
- Primary DI / UDI-DI
- 00847661002789 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, control
AmpliClear by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, control.
- Inocu Swabs — MICROBIOLOGICS, INC. · Class I
- Savanna — DIAGNOSTIC HYBRIDS, INC. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
- Savanna — DIAGNOSTIC HYBRIDS, INC. · Class II
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Alinity m — Abbott Molecular · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 11f38f7a-5a61-4b05-bce7-a6d814726552 36 fields · synced May 31, 2026