hemochroma PLUS Microcuvettes - The hemochroma PLUS Microcuvettes are used for - IMMUNOSTICS COMPANY, INC

Duns Number:119214195

Device Description: The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concentration in The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concentration in human whole blood along with the hemochroma PLUS Analyzer. The hemochroma PLUS Microcuvette is inserted into a holder of hemochroma PLUS Analyzer for quantification of hemoglobin in blood

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More Product Details

Catalog Number

100-202

Brand Name

hemochroma PLUS Microcuvettes

Version/Model Number

100-202

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

Yes

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

-

Product Code Details

Product Code

GKR

Product Code Name

SYSTEM, HEMOGLOBIN, AUTOMATED

Device Record Status

Public Device Record Key

c7d09436-71b1-48c4-a756-adcd2bb44f03

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNOSTICS COMPANY, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5