Pointe Magnesium Reagent - Pointe Magnesium Reagent packaged for use on the - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Pointe Magnesium Reagent packaged for use on the Mindray BA800. 5 x 25ml R1, 5 x 25ml R2 Pointe Magnesium Reagent packaged for use on the Mindray BA800. 5 x 25ml R1, 5 x 25ml R2. For the quantitative determination of magnesium in serum. For in vitro diagnostic use only.

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More Product Details

Catalog Number

16-HM929-250

Brand Name

Pointe Magnesium Reagent

Version/Model Number

16-HM929-250

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

K853592

Product Code Details

Product Code

JGJ

Product Code Name

Photometric Method, Magnesium

Device Record Status

Public Device Record Key

773a380b-be88-45ea-8e41-068bcf433167

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

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