Applied Biosystems - LIFE TECHNOLOGIES CORPORATION

Duns Number:080131636

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More Product Details

Catalog Number

-

Brand Name

Applied Biosystems

Version/Model Number

187265

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2018

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Device Record Status

Public Device Record Key

3aacc90c-6641-43e4-9383-d5bc85b4e7e3

Public Version Date

June 19, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 634
2 A medical device with a moderate to high risk that requires special controls. 77
3 A medical device with high risk that requires premarket approval 12