Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- Liquichek Urine Toxicology Control Level S1E (A human urine drugs of abuse control.) FDA UDI
- Model / Reference
- 438 FDA UDI
- Description
- Liquichek Urine Toxicology Control Level S1E (A human urine drugs of abuse control.) FDA UDI
Identifiers
- Catalog Number
- 438 FDA UDI
- Primary DI / UDI-DI
- 00847661000471 FDA UDI
- 510(k) Number
- K033924 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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: Multiple therapeutic drugs/drugs of abuse IVD, control
Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple therapeutic drugs/drugs of abuse IVD, control.
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- BLANK HAIR MATRIX — UTAK LABORATORIES, INC. · Class I
- DRUGS OF ABUSE LEVEL 1 — UTAK LABORATORIES, INC. · Class I
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Cleared under the same submission
K033924 also covers:
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
- Liquichek — Bio-Rad Laboratories
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 18ddeee6-bfdd-4b1a-82ad-0268428bd045 37 fields · synced May 30, 2026