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Atellica IM Fer

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM Fer FDA UDI
Generic Name
Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Ferritin (Fer) Atellica IM - RGT 90T FDA UDI
Model / Reference
10995569 FDA UDI
Description
Ferritin (Fer) Atellica IM - RGT 90T FDA UDI

Identifiers

Catalog Number
10995569 FDA UDI
Primary DI / UDI-DI
00630414598932 FDA UDI
510(k) Number
K171642 FDA UDI
FDA Product Code
DBF FDA UDI
GMDN Term
Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5340 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

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: Ferritin IVD, kit, chemiluminescent immunoassay

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

Similar devices

Also classified as Ferritin IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K171642 also covers:

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 57ed584f-fdf1-4ba0-8ab7-7f432d52f835 37 fields · synced Jun 6, 2026