Identity
- Trade Name
- LABScan3D™ FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes. FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes. FDA UDI
Identifiers
- Catalog Number
- LABSCNXS4 FDA UDI
- Primary DI / UDI-DI
- 00814695022588 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
LABScan3D™ by One Lambda, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.
- SSP DRB1*13 — CareDx AB · IVD Annex II List B
- SSP HLA-A*25 — CareDx AB · IVD Annex II List B
- SSP HLA-B*67 — CareDx AB · IVD Annex II List B
- SSP HLA-B*41 — CareDx AB · IVD Annex II List B
- SSP HLA-B*73 — CareDx AB · IVD Annex II List B
- AlloSeq Tx 9 — CareDx Pty Ltd · IVD Annex II List B
- SSP DRB4*01:03:01:02N — CareDx AB · IVD Annex II List B
- SSP HLA-A*80 — CareDx AB · IVD Annex II List B
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 II | Pending data |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (1)
- FDA UDI c07bb4b6-a43b-4590-96d8-3e1f97ddb2d3 35 fields · synced May 30, 2026