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AU/NZ SKREEN, Cutoff +50%, 5mL
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 19480200
Identity
- Trade Name
- AU/NZ SKREEN, Cutoff +50%, 5mL EUDAMEDDetectabuse FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- Detectabuse Liquid Control Urine EUDAMEDAU/NZ SKREEN, Cutoff +50%, 5mL FDA UDI
- Model / Reference
- 19480200 EUDAMEDFDA UDI
- Description
- AU/NZ SKREEN, Cutoff +50%, 5mL FDA UDI
Identifiers
- Catalog Number
- 19480200 FDA UDI
- Primary DI / UDI-DI
- 00850004812938 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850004812938 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
No
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
AU/NZ SKREEN, Cutoff +50%, 5mL by Biochemical Diagnostics Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00850004812938 | 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 00d860c9-2830-436e-a9b4-2004bb11f8b4 61 fields · synced Jul 9, 2026
- FDA UDI d0d61340-de11-467a-a574-74de2ed37c40 36 fields · synced May 30, 2026