Chloride LiquiColor® - Quantitative Colorimetric Determination of - STANBIO LABORATORY, L.P.

Duns Number:045361136

Device Description: Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF.

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More Product Details

Catalog Number

0210-250

Brand Name

Chloride LiquiColor®

Version/Model Number

0210-250

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

CHJ

Product Code Name

Mercuric Thiocyanate, Colorimetry, Chloride

Device Record Status

Public Device Record Key

62a78c88-e853-4ecc-98f7-c3895e14cd5f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANBIO LABORATORY, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 69
2 A medical device with a moderate to high risk that requires special controls. 86