JAS Diagnostics - CREATININE LIQUID (1 x 1 Liter + 1 x 5mL Standard) - DREW SCIENTIFIC, INC.

Duns Number:144968104

Device Description: CREATININE LIQUID (1 x 1 Liter + 1 x 5mL Standard)

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More Product Details

Catalog Number

-

Brand Name

JAS Diagnostics

Version/Model Number

DG-CRE2-1L

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003247

Product Code Details

Product Code

CGX

Product Code Name

Alkaline Picrate, Colorimetry, Creatinine

Device Record Status

Public Device Record Key

91fb77e0-d711-4006-9492-d2aa0edbddd1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DREW SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 85
2 A medical device with a moderate to high risk that requires special controls. 163