Identity
- Trade Name
- Lyphochek FDA UDI
- Generic Name
- Benzodiazepine group IVD, control FDA UDI
- Device Name
- Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA control.) FDA UDI
- Model / Reference
- 663 FDA UDI
- Description
- Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA control.) FDA UDI
Identifiers
- Catalog Number
- 663 FDA UDI
- Primary DI / UDI-DI
- 00847661000594 FDA UDI
- 510(k) Number
- K955153 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Benzodiazepine group 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: Benzodiazepine group IVD, controlTricyclic antidepressant IVD, control
Lyphochek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955153 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 05cabdb5-a57a-4122-b428-fdd59028b3ec 37 fields · synced Jun 8, 2026