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Atellica™ IM RBC FOL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica™ IM RBC FOL FDA UDI
Generic Name
Dithiothriotol (DTT) reagent IVD FDA UDI
Device Name
RBC Folate - Atellica IM - CONS - 4 x 30mL FDA UDI
Model / Reference
10995440 FDA UDI
Description
RBC Folate - Atellica IM - CONS - 4 x 30mL FDA UDI

Identifiers

Catalog Number
10995440 FDA UDI
Primary DI / UDI-DI
00630414597690 FDA UDI
510(k) Number
K172201 FDA UDI
FDA Product Code
CGN FDA UDI
GMDN Term
Dithiothriotol (DTT) reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1295 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: Dithiothriotol (DTT) reagent IVD

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

Similar devices

Also classified as Dithiothriotol (DTT) reagent IVD.

Cleared under the same submission

K172201 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 8b1fc077-1932-4543-91f3-638e25e7739c 37 fields · synced Jun 8, 2026