Identity
- Trade Name
- AccuTrak FDA UDI
- Generic Name
- Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control FDA UDI
- Device Name
- AccuTrak sFlt-1 Calibration Verification Panel FDA UDI
- Model / Reference
- 2400-0257 FDA UDI
- Description
- AccuTrak sFlt-1 Calibration Verification Panel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135655 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control
AccuTrak by LGC Clinical Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control.
- B.R.A.H.M.S sFlt-1 KRYPTOR LIN — B.R.A.H.M.S GmbH · Class I
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
- LGC Clinical Diagnostics, Inc.
Sources (1)
- FDA UDI 6d38f50d-e087-4160-bdfc-da5e138a3ecb 35 fields · synced Jun 9, 2026