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Atellica Ha1c_e High Volume Conversion Kit

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ATELLICA HA1C_E HIGH VOLUME CONVERSION KIT FDA UDI
Generic Name
Instrument/analyser specimen/reagent container carrier IVD FDA UDI
Device Name
HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH FDA UDI
Model / Reference
11470732 FDA UDI
Description
HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH FDA UDI

Identifiers

Catalog Number
11470732 FDA UDI
Primary DI / UDI-DI
00630414306179 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Instrument/analyser specimen/reagent container carrier IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Instrument/analyser specimen/reagent container carrier IVD

Atellica Ha1c_e High Volume Conversion Kit by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument/analyser specimen/reagent container carrier IVD.

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 c69c2167-a42c-4a9c-b5e8-5c7d607fd929 36 fields · synced May 30, 2026