Pointe Scientific, Inc. Glyco Standard - This product is for the purpose of standardizing - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: This product is for the purpose of standardizing results obtained from run to run in the q This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml

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More Product Details

Catalog Number

13-G7540-STD

Brand Name

Pointe Scientific, Inc. Glyco Standard

Version/Model Number

13-G7540-STD

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

K920449

Product Code Details

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Device Record Status

Public Device Record Key

280a1de3-825f-43e9-947f-dc450a0b5c63

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POINTE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 455
U Unclassified 2