LABType™ SSO Class II DRB1 Typing Test
FDA UDIEUDAMEDClass U (US FDA UDI)
Identity
- Trade Name
- LABType™ SSO Typing Test EUDAMEDLABType™ SSO Class II DRB1 Typing Test FDA UDILABType™ SSO Class I A Locus Typing Test FDA UDI
- Generic Name
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
- Device Name
- LABType™ SSO Class I A Locus Typing Test EUDAMEDDNA typing of HLA Class I or Class II alleles. FDA UDI
- Model / Reference
- RSSO1A EUDAMEDN/A FDA UDI
- Description
- DNA typing of HLA Class I or Class II alleles. FDA UDI
Identifiers
- Catalog Number
- RSSO2B1 FDA UDIRSSO1A FDA UDI
- Primary DI / UDI-DI
- 00812117011042 EUDAMEDFDA UDI00812117011080 FDA UDI
- Basic UDI-DI
- 081211701SSOAZ EUDAMED
- Direct Marketing DI
- 00812117011042 EUDAMED
- FDA Product Code
- MZI FDA UDI
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
- GMDN Term
- HLA class I & II antigen tissue typing IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class C EUDAMEDU FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
LABType™ SSO Class II DRB1 Typing Test by One Lambda, Inc. — Class U — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
Sources (3)
- FDA UDI 75c32d39-82ce-41e2-9082-00602e428b2e 36 fields · synced Jul 14, 2026
- FDA UDI 13c76652-623f-455e-9b45-2ca6661637b2 36 fields · synced May 30, 2026
- EUDAMED 2cf7ccf8-215b-4c03-93bf-28667c6d4db4 61 fields · synced Jul 14, 2026