VITROS - VITROS 5600 Integrated System - Box B - ORTHO-CLINICAL DIAGNOSTICS, INC.

Duns Number:623873044

Device Description: VITROS 5600 Integrated System - Box B

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More Product Details

Catalog Number

6802413B

Brand Name

VITROS

Version/Model Number

6802413B

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

Yes

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

-

FDA Premarket Submission

K081543

Product Code Details

Product Code

JJE

Product Code Name

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Device Record Status

Public Device Record Key

4911c594-1f27-4f19-9987-90ad4c6a194d

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO-CLINICAL DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 133
U Unclassified 1