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AutoDELFIA Neonatal 17α-OH-progesterone kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref B024-112
by Wallac Oy
Identity
- Trade Name
- AutoDELFIA Neonatal 17α-OH-progesterone kit EUDAMEDFDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- AutoDELFIA Neonatal 17α-OH-progesterone kit EUDAMEDFor the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. FDA UDI
- Model / Reference
- B024-112 EUDAMEDFDA UDI
- Description
- For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. FDA UDI
Identifiers
- Catalog Number
- B024-112 FDA UDI
- Primary DI / UDI-DI
- 06438147292486 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147292486 EUDAMED
- 510(k) Number
- K081922 FDA UDI
- FDA Product Code
- JLX FDA UDI
- EMDN Code
- W0102050107 17 OH PROGESTERONE EUDAMED
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1395 FDA UDI
- Market of Registration
- Finland 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
Yes
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
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
AutoDELFIA Neonatal 17α-OH-progesterone kit by Wallac Oy — 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-06438147292486 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED b7027114-4397-43f3-80b8-e0b919b3c1b2 61 fields · synced May 30, 2026
- FDA UDI a57e2204-71ed-42ea-a179-852e371eb23f 36 fields · synced May 30, 2026