Identity
- Trade Name
- Lyphochek FDA UDI
- Generic Name
- Folate (vitamin B9) IVD, control FDA UDI
- Device Name
- Lyphochek Whole Blood Control Level 3 (A human whole blood assayed control.) FDA UDI
- Model / Reference
- 563 FDA UDI
- Description
- Lyphochek Whole Blood Control Level 3 (A human whole blood assayed control.) FDA UDI
Identifiers
- Catalog Number
- 563 FDA UDI
- Primary DI / UDI-DI
- 00847661001676 FDA UDI
- 510(k) Number
- K022041 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Folate (vitamin B9) 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: Folate (vitamin B9) IVD, controlLead 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 Lead IVD, control.
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- Lead Level 1 — UTAK LABORATORIES, INC. · Class I
- Lyphochek — Bio-Rad Laboratories · Class I
- Lyphochek — Bio-Rad Laboratories · Class I
- Lyphochek — Bio-Rad Laboratories · Class I
Cleared under the same submission
K022041 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 7f1e48a8-3320-4a40-b8e0-107844580756 37 fields · synced May 30, 2026