POINTE SCIENTIFIC, INC.

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- Catalog Number : C7529-500

Device Description : For the quantitative determination of Calcium in serum or heparinized plasma.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7529-1L

Device Description : For the quantitative determination of Calcium in serum or heparinized plasma.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7503-STD

Device Description : Intended for use as an calcium standard for standardization or calibration of c Intended for use as an calcium standard for standardization or calibration of cresolphthalein complexone (CPC) or arsenazo calcium procedures.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7502-120

Device Description : For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7502-480

Device Description : For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7502-1L

Device Description : For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7504-STD

Device Description : Intended for use as an carbon dioxide standard for standardization or calibratio Intended for use as an carbon dioxide standard for standardization or calibration of PECP / NADH analog carbon dioxide procedures.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7506-50

Device Description : The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scie The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc. clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7590-50

Device Description : For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

- Catalog Number : C7591-50

Device Description : For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1