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

Duns Number:048144997

Device Description: This product is for the purpose of calibrating results in the quantitative determination o This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.

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More Product Details

Catalog Number

502-189

Brand Name

HbA1c Calibrator Set

Version/Model Number

4 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

d37a8d9e-545d-49c6-9a6a-ad445cb6c3bc

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