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

Mixture, Hematology Quality Control (JPK) (7) Assay, Glycosylated Hemoglobin (LCP) (1) Calibrator For Cell Indices (KRX) (1) Products, Red-Cell Lysing Products (GGK) (1)

Premarket Exempt

Yes No

Clear

Drew - 00817274020241 Catalog Number :

Device Description : DS360 Column (1,000-Test)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020258 Catalog Number :

Device Description : EX-CAL (1 x 3mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : KRX

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020265 Catalog Number :

Device Description : Drew-3 Reagent Pack (360 test) DREW3-PAC

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020272 Catalog Number :

Device Description : EX-TROL Normal (18 x 2.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020289 Catalog Number :

Device Description : EX-TROL High (1 x 2.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020296 Catalog Number :

Device Description : EX-TROL Low (1 x 2.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020302 Catalog Number :

Device Description : EX-TROL Normal (1 x 2.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020319 Catalog Number :

Device Description : EX-TROL Tri-level (3 x 6 x 2.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020326 Catalog Number :

Device Description : Control Kit, 3-Level (9 x 3ml)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020333 Catalog Number :

Device Description : EX-TROL Tri-level (3 x 6 x 4.5mL) Control

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

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