Ready Cells - RC RMIX RINSE BUFFER - DIAGNOSTIC HYBRIDS, INC.

Duns Number:117359612

Device Description: RC RMIX RINSE BUFFER

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

05-360075

Brand Name

Ready Cells

Version/Model Number

05-360075

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

KIT

Product Code Name

MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE

Device Record Status

Public Device Record Key

125c9692-3bf3-4f58-94b4-38d571fbc68f

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAGNOSTIC HYBRIDS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 549
2 A medical device with a moderate to high risk that requires special controls. 68