IMMUNOSTICS COMPANY, INC

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Device Description : The hemochroma PLUS Analyzer calculates the test result automatically and displa The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.

Device Class : 2

Duns Number: 119214195

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

Device Description : The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concent 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

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 200

Device Description : hemochroma PLUS Controls are intended for use as quality control material to ass hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin concentration.

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : GGM

Prescription Use : Yes

Device Count : 40

Device Description : hemochroma PLUS Optical System Check is intended to assure the performance of th hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer.

Device Class : 2

Duns Number: 119214195

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

Device Description : 1 hemochroma PLUS Analyzer+100 Microcuvettes+1 optical system check

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 100