Pointe Scientific Inc. - Alkaline Phosphatase Reagent Set for the - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphata Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 4 x 100ml, 4 x 23ml

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More Product Details

Catalog Number

HA916-492

Brand Name

Pointe Scientific Inc.

Version/Model Number

HA916-492

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

K973588

Product Code Details

Product Code

CJE

Product Code Name

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Device Record Status

Public Device Record Key

da8cbc9f-ac7f-4714-901f-74b10f116b96

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