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AutoDELFIA Neonatal 17α-OH-progesterone kit

FDA UDIEUDAMED

Class I (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
AutoDELFIA Neonatal 17α-OH-progesterone kit FDA UDI
Generic Name
17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. FDA UDI
Model / Reference
B024-104 FDA UDI
Description
For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood. FDA UDI

Identifiers

Catalog Number
B024-104 FDA UDI
Primary DI / UDI-DI
06438147292523 FDA UDI
510(k) Number
K081922 FDA UDI
FDA Product Code
JLX FDA UDI
GMDN Term
17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1395 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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, Inc. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (2)

  • FDA UDI 63823ae8-534b-48c1-a3d1-6330849358e2 37 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026