Identity
- Trade Name
- Lyphochek FDA UDI
- Generic Name
- Multiple tissue-associated protein/tumour marker IVD, control FDA UDI
- Device Name
- Lyphochek Tumor Marker Plus Control Trilevel MiniPak (A human based assayed tumor marker control.) FDA UDI
- Model / Reference
- 368X FDA UDI
- Description
- Lyphochek Tumor Marker Plus Control Trilevel MiniPak (A human based assayed tumor marker control.) FDA UDI
Identifiers
- Catalog Number
- 368X FDA UDI
- Primary DI / UDI-DI
- 00847661003403 FDA UDI
- 510(k) Number
- K082036 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple tissue-associated protein/tumour marker 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: Multiple tissue-associated protein/tumour marker IVD, control
Lyphochek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple tissue-associated protein/tumour marker IVD, control.
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- Elecsys PreciControl Tumor Marker — Roche Diagnostics Corp. · Class I
- MAS T-Marker Liquid Assayed Tumor Marker Control — Microgenics Corporation · Class I
- Audit MicroControls Control FD HE4, HER2 Tumor Markers — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD HE4, HER2 Tumor Markers — Aalto Scientific, Ltd.
Cleared under the same submission
K082036 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 545eba13-e2f4-4625-ab99-aca8eac2fb44 37 fields · synced Jun 7, 2026