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

Enzymatic Method, Ammonia (JIF) (4) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (3) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (2) Saccharogenic, Amylase (CIJ) (1)

Premarket Exempt

No Yes

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POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010148 Catalog Number : A7516-450

Device Description : For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010155 Catalog Number : A7516-625

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALT (SGPT) Liquid - 00811727010216 Catalog Number : A7526-150

Device Description : For the quantitative determination of Alanine Aminotransferase in serum.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALT (SGPT) Liquid - 00811727010223 Catalog Number : A7526-450

Device Description : For the quantitative determination of Alanine Aminotransferase in serum.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC ALT (SGPT) Liquid - 00811727010230 Catalog Number : A7526-625

Device Description : For the quantitative determination of Alanine Aminotransferase in serum.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC AMMONIA - 00811727010247 Catalog Number : A7553-34

Device Description : This reagent is intended for the enzymatic measurement of ammonia in plasma. Fo This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JIF

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC AMMONIA - 00811727010254 Catalog Number : A7553-85

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JIF

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Ammonia Standard 1 - 00811727010261 Catalog Number : A7553-STD100

Device Description : The Ammonia Standards are intended for the calibration of ammonia assays.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JIF

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Ammonia Standard 5 - 00811727010278 Catalog Number : A7553-STD500

Device Description : The Ammonia Standards are intended for the calibration of ammonia assays.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : JIF

Prescription Use : Yes

Device Count : 1

POINTE SCIENTIFIC Amylase - 00811727010285 Catalog Number : A7564-60

Device Description : For the quantitative kinetic determination of a-amylase activity in human serum For the quantitative kinetic determination of a-amylase activity in human serum using a manual or automated procedure.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : CIJ

Prescription Use : Yes

Device Count : 1

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