Identity
- Trade Name
- Lyphochek FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- Lyphochek Drug Free Serum MiniPak (A human drug free serum control.) FDA UDI
- Model / Reference
- 456X FDA UDI
- Description
- Lyphochek Drug Free Serum MiniPak (A human drug free serum control.) FDA UDI
Identifiers
- Catalog Number
- 456X FDA UDI
- Primary DI / UDI-DI
- 00847661002055 FDA UDI
- 510(k) Number
- K852414 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
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
K852414 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 935d797e-3cf2-4e63-8388-4019ceec9766 37 fields · synced Jun 8, 2026