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VIDAS® Estradiol II

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VIDAS® Estradiol II FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
VIDAS ® Estradiol II (E2 II) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of total estradiol concentration in human serum or plasma. FDA UDI
Model / Reference
30431-01 FDA UDI
Description
VIDAS ® Estradiol II (E2 II) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of total estradiol concentration in human serum or plasma. FDA UDI

Identifiers

Primary DI / UDI-DI
03573026161637 FDA UDI
510(k) Number
K955647 FDA UDI
FDA Product Code
CHP FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) 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

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: Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

VIDAS® Estradiol II by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 73643322-44c4-4f35-9ba2-2dc5bcbb84ee 35 fields · synced Jun 8, 2026