VITROS - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 - ORTHO CLINICAL DIAGNOSTICS

Duns Number:215865786

Device Description: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator

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More Product Details

Catalog Number

6199923

Brand Name

VITROS

Version/Model Number

6199923

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

QKO

Product Code Name

Reagent, coronavirus serological

Device Record Status

Public Device Record Key

d1688fc7-f33a-4f9f-aa3d-9c5c8bb868fb

Public Version Date

March 30, 2021

Public Version Number

1

DI Record Publish Date

March 22, 2021

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