POINTE SCIENTIFIC Fructosamine Calibrator - The Fructosamine calibrator is derived from - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: The Fructosamine calibrator is derived from pooled human serum containing buffers, stabili The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay.

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More Product Details

Catalog Number

F7546-CAL

Brand Name

POINTE SCIENTIFIC Fructosamine Calibrator

Version/Model Number

F7546-CAL

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

K993590

Product Code Details

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Device Record Status

Public Device Record Key

7cd6f9b3-6da4-4c18-b09d-7a1299fcc7bb

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