DREW SCIENTIFIC, INC.

DREW SCIENTIFIC, INC.

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Filters

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

Assay, Glycosylated Hemoglobin (LCP) (3) Calibrator, Secondary (JIT) (3) Mixture, Hematology Quality Control (JPK) (3) Products, Red-Cell Lysing Products (GGK) (1)

Premarket Exempt

No Yes

Clear

Drew Scientific - 00817274020135 Catalog Number :

Device Description : Gold Kit 80-100 Test

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020142 Catalog Number :

Device Description : DS5 HbA1c Control (2-level) (3x 0.5mL L1, 3x 0.5mL L2)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020159 Catalog Number :

Device Description : DS5 HbA1c Control (2-level) (2 x 3 x 0.5mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew - 00817274020166 Catalog Number :

Device Description : DS360 - HbA1c Control (3x 0.5mL L1, 3x 0.5mL L2, 1x 4mL Diluent, 1x 100mL Hemolyzer)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020173 Catalog Number :

Device Description : DS5 Pink Kit (300 test)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020197 Catalog Number :

Device Description : Pink Kit Hemolyzer (440mL)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020203 Catalog Number :

Device Description : DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020210 Catalog Number :

Device Description : DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020227 Catalog Number :

Device Description : DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020234 Catalog Number :

Device Description : DS360 Reagent Test Kit (500 tests)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

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