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

Drug Specific Control Materials (LAS) (2) U.V. Method, Cpk Isoenzymes (JHW) (2) Calibrators, Drug Specific (DLJ) (1)

Premarket Exempt

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Pointe Meprobamate Calibrator (400 ng/mL) High - 00811727018434 Catalog Number : 60-MB0750-5

Device Description : Pointe Meprobamate Calibrator (400 ng/mL) High 1 x 5 mL The Pointe Carisoprodol Pointe Meprobamate Calibrator (400 ng/mL) High 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : Yes

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Pointe Meprobamate Control (75 ng/mL) Level 1 - 00811727018441 Catalog Number : 60-MB0754-5

Device Description : Pointe Meprobamate Control (75 ng/mL) Level 1 1 x 5 mL The Pointe Carisoprodol M Pointe Meprobamate Control (75 ng/mL) Level 1 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Pointe Meprobamate Control (125 ng/mL) Level 2 - 00811727018458 Catalog Number : 60-MB0756-5

Device Description : Pointe Meprobamate Control (125 ng/mL) Level 2 1 x 5 mL The Pointe Carisoprodol Pointe Meprobamate Control (125 ng/mL) Level 2 1 x 5 mL The Pointe Carisoprodol Metabolite (SOMA) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Carisoprodol Metabolite (SOMA) Reagent Set (Ref# 60-CM0740-100/60-CM0740-1L) on a number of automated clinical chemistry analyzers.

Device Class : 1

Duns Number: 045623154

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Pointe Scientific CK-MB - 00811727018632 Catalog Number : C7563-30

Device Description : Pointe Scientific Creatine Kinase-MB, 2-part liquid. 1x24 ml R1, 1x6 ml R2. For Pointe Scientific Creatine Kinase-MB, 2-part liquid. 1x24 ml R1, 1x6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : JHW

Prescription Use : Yes

Device Count : 1

Pointe Scientific CK-MB - 00811727018649 Catalog Number : C7563-90

Device Description : Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Qu Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only.

Device Class : 2

Duns Number: 045623154

Premarket Exempt : No

Product Code : JHW

Prescription Use : Yes

Device Count : 1

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