Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Ammonia IVD, control FDA UDI
- Device Name
- Liquichek Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) FDA UDI
- Model / Reference
- 546 FDA UDI
- Description
- Liquichek Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) FDA UDI
Identifiers
- Catalog Number
- 546 FDA UDI
- Primary DI / UDI-DI
- 00847661000969 FDA UDI
- 510(k) Number
- K955024 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Ammonia 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
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
Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ammonia IVD, control.
- Ammonia Standard — CLINIQA CORPORATION · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Ammonia Alcohol Control Level 2 Set 3x5mL — QUANTIMETRIX CORP. · Class I
- Ammonia Alcohol Control Level 1 Set 3x5mL — QUANTIMETRIX CORP. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Ammonia Alcohol Control Level 3 Set 3x5mL — QUANTIMETRIX CORP. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Liquichek — Bio-Rad Laboratories · Class I
Cleared under the same submission
K955024 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 26539132-a070-46ba-83ed-ec3350bca4f7 37 fields · synced Jun 8, 2026