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Progest-Us

FDA UDI

Class I (US FDA UDI)

by Cisbio Bioassays

Identity

Trade Name
PROGEST-US FDA UDI
Generic Name
Progesterone IVD, kit, radioimmunoassay FDA UDI
Device Name
Radioimmunometric assay kit for the quantitative determination of progesterone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI
Model / Reference
PROGEST-US FDA UDI
Description
Radioimmunometric assay kit for the quantitative determination of progesterone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI

Identifiers

Catalog Number
PROGEST-US FDA UDI
Primary DI / UDI-DI
03770024321609 FDA UDI
FDA Product Code
JLS FDA UDI
GMDN Term
Progesterone IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1620 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Progesterone IVD, kit, radioimmunoassay

Progest-Us by Cisbio Bioassays — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Progesterone IVD, kit, radioimmunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cisbio Bioassays

Sources (1)

  • FDA UDI fcf972e8-a467-4b12-9830-1ec302355020 36 fields · synced May 30, 2026