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Atellica IM eE2

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM eE2 FDA UDI
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Estradiol (eE2) Atellica IM - RGT - 100T FDA UDI
Model / Reference
10995561 FDA UDI
Description
Estradiol (eE2) Atellica IM - RGT - 100T FDA UDI

Identifiers

Catalog Number
10995561 FDA UDI
Primary DI / UDI-DI
00630414598857 FDA UDI
FDA Product Code
CHP FDA UDI
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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, chemiluminescent immunoassay

Atellica IM eE2 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 1b31de9d-6f5c-4ee9-8878-8d046d3f499b 36 fields · synced Jun 8, 2026