HbA1c Quality Control Kit Level 2 - HbA1c Quality Control Kit Level 2 for use with - MEDICA CORPORATION

Duns Number:112942404

Device Description: HbA1c Quality Control Kit Level 2 for use with EasyRA Analyzer

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More Product Details

Catalog Number

10796

Brand Name

HbA1c Quality Control Kit Level 2

Version/Model Number

10796

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120497

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

00b3685c-dcae-46fc-bc4b-8601eaa1b4fa

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 82