HbA1c Control Set - This product is for the purpose of monitoring - CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Duns Number:048144997

Device Description: This product is for the purpose of monitoring accuracy and precision in the quantitative d

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More Product Details

Catalog Number

502-156

Brand Name

HbA1c Control Set

Version/Model Number

L1 x 2 x 0.5mL, L2 x 2 x 0.5mL

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)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Device Record Status

Public Device Record Key

9c9f522e-5a16-4b3f-8b08-0363b6c8b44f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINICAL DIAGNOSTIC SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 8