PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE) - The chamber features a sample loading system that - BIOMERIEUX SA

Duns Number:276816717

Device Description: The chamber features a sample loading system that places a spot on the microscope slide.

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More Product Details

Catalog Number

-

Brand Name

PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE)

Version/Model Number

PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE)

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

Yes

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

KPA

Product Code Name

Slide stainer, automated

Device Record Status

Public Device Record Key

da306cd2-cb7f-4c6d-a4ac-c4e5bf81a91e

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMERIEUX SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 156
3 A medical device with high risk that requires premarket approval 3