Pointe Scientific, Inc. Albumin - Pointe Scientific, Inc. Albumin Reagent is for - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Pointe Scientific, Inc. Albumin Reagent is for the quantitative determination of Albumin i

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More Product Details

Catalog Number

OA902-792

Brand Name

Pointe Scientific, Inc. Albumin

Version/Model Number

OA902-792

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

K822471

Product Code Details

Product Code

CIX

Product Code Name

Bromcresol Green Dye-Binding, Albumin

Device Record Status

Public Device Record Key

7e5bd8da-af97-4669-88f9-4c92b940eb41

Public Version Date

June 10, 2022

Public Version Number

4

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