Atellica IM ThCG - HCG Total (ThCG) - Atellica IM - RGT - 450T - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: HCG Total (ThCG) - Atellica IM - RGT - 450T

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More Product Details

Catalog Number

11206261

Brand Name

Atellica IM ThCG

Version/Model Number

11206261

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172322,K172322

Product Code Details

Product Code

JHI

Product Code Name

Visual, pregnancy hCG, prescription use

Device Record Status

Public Device Record Key

9b6c7f7c-5222-45e8-8972-0e8150a0f7fc

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

May 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7