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Estr-S-Us

FDA UDI

Class I (US FDA UDI)

by Cisbio Bioassays

Identity

Trade Name
ESTR-S-US FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay FDA UDI
Device Name
Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI
Model / Reference
ESTR-S-US FDA UDI
Description
Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI

Identifiers

Catalog Number
ESTR-S-US FDA UDI
Primary DI / UDI-DI
03770024321586 FDA UDI
FDA Product Code
CHP FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1260 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: Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay

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

Similar devices

Also classified as Estradiol (oestradiol) (E2) 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 29e3b89b-9a95-487e-b331-5e40dda9d73f 36 fields · synced May 30, 2026