POINTE SCIENTIFIC, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Urease And Glutamic Dehydrogenase, Urea Nitrogen (CDQ) (4) Cresolphthalein Complexone, Calcium (CIC) (3) Diazo Colorimetry, Bilirubin (CIG) (2) Berthelot Indophenol, Urea Nitrogen (CDL) (1)

Premarket Exempt

No Yes

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POINTE SCIENTIFIC Bilirubin, Total - 00811727010445 Catalog Number : B7576-500

Device Description : For the quantitative determination of direct bilirubin in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Bilirubin, Total - 00811727010452 Catalog Number : B7576-1L

Device Description : For the quantitative determination of direct bilirubin in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC BUN Liquid - 00811727010537 Catalog Number : B7552-150

Device Description : For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC BUN Liquid - 00811727010544 Catalog Number : B7552-450

Device Description : For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC BUN Liquid - 00811727010551 Catalog Number : B7552-625

Device Description : For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC BUN (Berthelot) - 00811727010568 Catalog Number : B7551-120

Device Description : For in vitro diagnostic use in the quantitative colorimetric determination of ur For in vitro diagnostic use in the quantitative colorimetric determination of urea nitrogen in serum.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CDL

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC BUN Standard - 00811727010575 Catalog Number : B7550-STD

Device Description : Intended for use as an BUN (Urea Nitrogen) standard for standardization or calib Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Calcium (2 part) - 00811727010582 Catalog Number : C7503-120

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

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Calcium (2 part) - 00811727010599 Catalog Number : C7503-480

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

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Calcium Arsenazo - 00811727010629 Catalog Number : C7529-120

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

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