ARCHITECT - ARCHITECT 2nd Generation Testosterone Reagent Kit - Abbott GmbH

Duns Number:315786293

Device Description: ARCHITECT 2nd Generation Testosterone Reagent Kit

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More Product Details

Catalog Number

02P1327

Brand Name

ARCHITECT

Version/Model Number

2P13-27

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CDZ

Product Code Name

RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Device Record Status

Public Device Record Key

917574dc-5ca3-485e-b729-2ca79cfb09be

Public Version Date

June 22, 2020

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 185
3 A medical device with high risk that requires premarket approval 13