Salivabuse - CP-OF Panel, +50%, 20mL - BIOCHEMICAL DIAGNOSTICS INC

Duns Number:028007698

Device Description: CP-OF Panel, +50%, 20mL

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More Product Details

Catalog Number

18100150

Brand Name

Salivabuse

Version/Model Number

18100150

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

DIF

Product Code Name

Drug Mixture Control Materials

Device Record Status

Public Device Record Key

e96481c0-38a6-41c4-af48-6f7b3f12cab4

Public Version Date

February 11, 2020

Public Version Number

1

DI Record Publish Date

February 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCHEMICAL DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388