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Buprenorphine Enzyme Immunoassay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 08362955190
Identity
- Trade Name
- Buprenorphine Enzyme Immunoassay EUDAMEDFDA UDI
- Generic Name
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Buprenorphine Enzyme Immunoassay EUDAMED200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL. FDA UDI
- Model / Reference
- 08362955190 EUDAMEDFDA UDI
- Description
- 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL. FDA UDI
Identifiers
- Catalog Number
- 08362955190 FDA UDI
- Primary DI / UDI-DI
- 00850624008018 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850624008EIABUP02C9 EUDAMED
- Direct Marketing DI
- 00850624008018 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090117 BUPRENORPHINE EUDAMED
- GMDN Term
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Buprenorphine Enzyme Immunoassay by Lin-Zhi International, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850624008EIABUP02C9 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
- EUDAMED SRN
- US-MF-000003373
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED e6118b0a-d423-4a68-aef9-a91133e8fb94 61 fields · synced Oct 6, 2026
- FDA UDI 0fd06983-f9ee-421d-862d-f9e952f06720 35 fields · synced May 30, 2026