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Atellica IM DHEAS2 MCM SET

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM DHEAS2 MCM SET FDA UDI
Generic Name
Dehydroepiandrosterone sulfate (DHEAS) IVD, control FDA UDI
Device Name
Atellica IM DHEASII MCM SET FDA UDI
Model / Reference
11209195 FDA UDI
Description
Atellica IM DHEASII MCM SET FDA UDI

Identifiers

Catalog Number
11209195 FDA UDI
Primary DI / UDI-DI
00630414632940 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Dehydroepiandrosterone sulfate (DHEAS) IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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: Dehydroepiandrosterone sulfate (DHEAS) IVD, control

Atellica IM DHEAS2 MCM SET by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dehydroepiandrosterone sulfate (DHEAS) IVD, control.

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 d122a506-06ee-4123-a690-7bc93295dec2 36 fields · synced May 31, 2026