Identity
- Trade Name
- Ammonia Alcohol Control Level 2 Set 3x5mL FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, control FDA UDI
- Device Name
- The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI
- Model / Reference
- 1312-31 FDA UDI
- Description
- The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI
Identifiers
- Catalog Number
- 1312-31 FDA UDI
- Primary DI / UDI-DI
- 00896863002240 FDA UDI
- 510(k) Number
- K913346 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Ethanol (ETOH) 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
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: Ethanol (ETOH) IVD, controlAmmonia IVD, control
Ammonia Alcohol Control Level 2 Set 3x5mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Quantimetrix Corp.
Sources (1)
- FDA UDI 18abcc1c-236b-49f8-86a5-8747c838afe9 37 fields · synced May 30, 2026