Identity
- Trade Name
- LABScreen™ PRA Class II - Group 1 Sample FDA UDI
- Generic Name
- HLA class I & II antibody screening IVD, kit, multiplex FDA UDI
- Device Name
- LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology FDA UDI
Identifiers
- Catalog Number
- LS2PRAS FDA UDI
- Primary DI / UDI-DI
- 00812117018898 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- HLA class I & II antibody screening IVD, kit, multiplex FDA UDI
Classification
- Device Class
- U 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: HLA class I & II antibody screening IVD, kit, multiplex
LABScreen™ PRA Class II - Group 1 Sample by One Lambda, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HLA class I & II antibody screening IVD, kit, multiplex.
- PE - Conjugated Goat Anti-Human IgG (100X) — ONE LAMBDA, INC. · U
- FlowPRA™ Class I Screening Beads — ONE LAMBDA, INC.
- PE Conjugated Goat Anti-Human IgG — ONE LAMBDA, INC. · U
- FlowPRA™ HLA Class I & II Beads - Sample — ONE LAMBDA, INC.
- FlowPRA™ Single Antigen HLA Class I - 3 Antibody Detection Test — ONE LAMBDA, INC.
- FlowPRA™ Single Antigen HLA Class II - 4 Antibody Detection Test — ONE LAMBDA, INC.
- FlowPRA™ Specific HLA Class II Antibody Detection Test — ONE LAMBDA, INC.
- FlowPRA™ HLA Class I & II Screening Test — ONE LAMBDA, INC.
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (1)
- FDA UDI 70bad435-9a72-449a-a68d-06247769739c 36 fields · synced May 30, 2026