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PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 702032
Identity
- Trade Name
- PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL EUDAMED
- Device Name
- PREGNANCY-SKREEN hCG LIQUID CONTROLS EUDAMED
- Model / Reference
- 702032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810042683150 EUDAMED
- Basic UDI-DI
- B-00810042683150 EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL by Biochemical Diagnostics Inc — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050328 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00810042683150 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics, Inc
- EUDAMED SRN
- US-MF-000025179
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 235755b5-73fa-401a-9267-bdb85142a172 61 fields · synced Jul 18, 2026
- FDA 510(k) K050328 1 fields · synced May 18, 2026