Identity
- Trade Name
- LABScreen™ Negative Control EUDAMEDLABScreen Negative Control FDA UDI
- Generic Name
- HLA class I & II antibody screening IVD, kit, multiplex FDA UDI
- Device Name
- LABScreen EUDAMEDLABScreen products are intended for use in detection of HLA antibody using flowcytometric technology FDA UDI
- Model / Reference
- LS-NC EUDAMEDN/A FDA UDI
- Description
- LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology FDA UDI
Identifiers
- Catalog Number
- LS-NC FDA UDI
- Primary DI / UDI-DI
- 00812117015224 EUDAMEDFDA UDI
- Basic UDI-DI
- 081211701LSLJ EUDAMED
- FDA Product Code
- MZI FDA UDI
- EMDN Code
- W01030402 HLA ANTIBODY SCREENING EUDAMED
- GMDN Term
- HLA class I & II antibody screening IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class C EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
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 antibody screening IVD, kit, multiplex
LABScreen Negative Control by One Lambda, Inc. — Class U — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (2)
- FDA UDI e76f2f44-48e9-4d55-9706-316594d05828 36 fields · synced Jul 8, 2026
- EUDAMED ca2ad144-fe80-4cf7-9830-214c0a7fa094 61 fields · synced Jul 8, 2026