Identity
- Trade Name
- Lyphochek FDA UDI
- Generic Name
- Lead IVD, control FDA UDI
- Device Name
- Lyphochek Whole Blood Control Level 1 (A human whole blood assayed control.) FDA UDI
- Model / Reference
- 561 FDA UDI
- Description
- Lyphochek Whole Blood Control Level 1 (A human whole blood assayed control.) FDA UDI
Identifiers
- Catalog Number
- 561 FDA UDI
- Primary DI / UDI-DI
- 00847661001652 FDA UDI
- 510(k) Number
- K022041 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Lead 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
Similar devices
Also classified as Lead IVD, control.
- Lead Level 2 — UTAK LABORATORIES, INC. · Class I
- Lead Level 3 — UTAK LABORATORIES, INC. · Class I
- 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 277647ea-60ac-4c9f-9b2d-d6ce165893d5 37 fields · synced Jun 1, 2026