Kallestad - Kallestad Crithidia luciliae Substrate - Bio-RAD Laboratories, Inc.

Duns Number:844766394

Device Description: Kallestad Crithidia luciliae Substrate

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More Product Details

Catalog Number

30404

Brand Name

Kallestad

Version/Model Number

30404

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K780899

Product Code Details

Product Code

DHN

Product Code Name

ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Device Record Status

Public Device Record Key

3148d347-5ac1-4d5b-b20d-24981e66e4c6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 98
3 A medical device with high risk that requires premarket approval 30