HbA1c II CALIBRATOR SET (HbA1c II CAL) - The HbA1c II Calibrator is intended for use in - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: The HbA1c II Calibrator is intended for use in the calibration of the HbA1c II assay.

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More Product Details

Catalog Number

HA8124

Brand Name

HbA1c II CALIBRATOR SET (HbA1c II CAL)

Version/Model Number

HA8124

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

JIT

Product Code Name

Calibrator, Secondary

Device Record Status

Public Device Record Key

3649352d-8c59-4e4f-ba70-a939a7414ab6

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258