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GSP Neonatal 17α-OH-progesterone kit

FDA UDI

Class I (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
GSP Neonatal 17α-OH-progesterone kit FDA UDI
Generic Name
17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-progesterone (17-OHP) in dried blood. FDA UDI
Model / Reference
3305-001U FDA UDI
Description
Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-progesterone (17-OHP) in dried blood. FDA UDI

Identifiers

Catalog Number
3305-001U FDA UDI
Primary DI / UDI-DI
06438147321209 FDA UDI
510(k) Number
K100682 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
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

Category: 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay

GSP Neonatal 17α-OH-progesterone kit by Wallac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as 17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI c5c1adbb-8b21-40ed-9d6c-0e19d2d087f7 36 fields · synced May 30, 2026