Identity
- Trade Name
- Ammonia Reagent FDA UDI
- Generic Name
- Ammonia IVD, reagent FDA UDI
- Device Name
- Ammonia Reagent FDA UDI
- Model / Reference
- R85444 FDA UDI
- Description
- Ammonia Reagent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817238011438 FDA UDI
- 510(k) Number
- K864706 FDA UDI
- FDA Product Code
- JIF FDA UDI
- GMDN Term
- Ammonia IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1065 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Category: Ammonia IVD, reagent
Ammonia Reagent by Cliniqa Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ammonia IVD, reagent.
- VITROS — Ortho-Clinical Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Cliniqa Corporation
Sources (1)
- FDA UDI 70d0e6c4-0ae7-4544-ab92-33a32237097a 34 fields · synced Jun 8, 2026