VITROS - VITROS Immunodiagnostic ProductsTestosterone - ORTHO CLINICAL DIAGNOSTICS

Duns Number:215865786

Device Description: VITROS Immunodiagnostic ProductsTestosterone Calibrators

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More Product Details

Catalog Number

1306026

Brand Name

VITROS

Version/Model Number

1306026

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

K983507

Product Code Details

Product Code

JIX

Product Code Name

CALIBRATOR, MULTI-ANALYTE MIXTURE

Device Record Status

Public Device Record Key

c6a58e69-5c09-47d3-ad3d-c77fa82c721c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO CLINICAL DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 17