VITROS - VITROS Immunodiagnostic Products TSH Reagent Pack - ORTHO CLINICAL DIAGNOSTICS

Duns Number:215865786

Device Description: VITROS Immunodiagnostic Products TSH Reagent Pack

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More Product Details

Catalog Number

1912997

Brand Name

VITROS

Version/Model Number

1912997

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

JLW

Product Code Name

RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Device Record Status

Public Device Record Key

9b0992fa-a4d5-465e-8c03-68bb805c2d6f

Public Version Date

March 29, 2018

Public Version Number

2

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