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hCG 4mL Kit Neg/Pos dropper
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 18030367
Identity
- Trade Name
- hCG 4mL Kit Neg/Pos dropper EUDAMEDPregnancy-Skreen FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-core fragment IVD, control FDA UDI
- Device Name
- PREGNANCY-SKREEN hCG LIQUID CONTROLS EUDAMEDHCG Urine 2x4mL dropper Kit FDA UDI
- Model / Reference
- 18030367 EUDAMEDFDA UDI
- Description
- HCG Urine 2x4mL dropper Kit FDA UDI
Identifiers
- Catalog Number
- 18030367 FDA UDI
- Primary DI / UDI-DI
- 00810042681156 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810042681156 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
- GMDN Term
- Human chorionic gonadotropin beta-core fragment IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
hCG 4mL Kit Neg/Pos dropper 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-00810042681156 | 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 03adeb21-1756-4cf2-a6de-760ed7be98c0 61 fields · synced Jul 18, 2026
- FDA UDI 302daadc-3c7f-4f4f-b9d6-750fecf22550 35 fields · synced May 30, 2026