Catalog Number

-

Brand Name

Cal-Lyse™ Lysing Solution 250 Tests

Version/Model Number

GAS010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2022

Issuing Agency

In GS1

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

GGK

Product Code Name

PRODUCTS, RED-CELL LYSING PRODUCTS

Public Device Record Key

0e786940-1db7-4afc-a554-e36fbcb61e90

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-