Direct Glycohemoglobin (HbA1c) Control Set - For use as controls in the Quantitative - STANBIO LABORATORY, L.P.

Duns Number:045361136

Device Description: For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood.

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More Product Details

Catalog Number

0355-201

Brand Name

Direct Glycohemoglobin (HbA1c) Control Set

Version/Model Number

0355-201

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

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Device Record Status

Public Device Record Key

de3690c0-cf1e-49f4-a6a6-07c942e70b51

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