Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, control FDA UDI
- Device Name
- Liquichek Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) FDA UDI
- Model / Reference
- 273 FDA UDI
- Description
- Liquichek Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) FDA UDI
Identifiers
- Catalog Number
- 273 FDA UDI
- Primary DI / UDI-DI
- 00847661005094 FDA UDI
- 510(k) Number
- K123198 FDA UDI
- FDA Product Code
- JJY 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
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
K123198 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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 4a16d011-5cd3-4b68-88d9-8c8a854d4f8c 37 fields · synced Jun 1, 2026