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NEG & SS(LM)MOB, 2x20ml Neg/Pos kitbox
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 820000
Identity
- Trade Name
- NEG & SS(LM)MOB, 2x20ml Neg/Pos kitbox EUDAMEDDetectabuse FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- Detectabuse Liquid Control Urine EUDAMEDStat-Skreen (LM) with MDMA, Oxy, Bup, kitbox 2x20mL FDA UDI
- Model / Reference
- 820000 EUDAMEDFDA UDI
- Description
- Stat-Skreen (LM) with MDMA, Oxy, Bup, kitbox 2x20mL FDA UDI
Identifiers
- Catalog Number
- 820000 FDA UDI
- Primary DI / UDI-DI
- 00810042680951 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810042680951 EUDAMED
- FDA Product Code
- DIF FDA UDI
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
- GMDN Term
- Multiple drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
NEG & SS(LM)MOB, 2x20ml Neg/Pos kitbox by Biochemical Diagnostics Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00810042680951 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics, Inc
- EUDAMED SRN
- US-MF-000025179
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e4ff264b-d8c2-4a01-b5d2-3314baf60ab9 61 fields · synced Jun 17, 2026
- FDA UDI 6463fb9f-e31e-499e-94c2-c826b4dd6fa0 36 fields · synced May 30, 2026