Atellica IM TSTII - Testoterone II (TSTII) Atellica IM - RGT 100T - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: Testoterone II (TSTII) Atellica IM - RGT 100T

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More Product Details

Catalog Number

10995708

Brand Name

Atellica IM TSTII

Version/Model Number

10995708

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

K151986

Product Code Details

Product Code

CDZ

Product Code Name

RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Device Record Status

Public Device Record Key

65166d4e-31f1-4be6-a688-b978b2d4a63c

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 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