DREW 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

Catalytic Methods, Amylase (JFJ) (2) Calibrator, Multi-Analyte Mixture (JIX) (2) Albumin, Antigen, Antiserum, Control (DCF) (2) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1) Detergent (JCB) (1) Glucose Oxidase, Glucose (CGA) (1) Calibrator, Secondary (JIT) (1)

Premarket Exempt

Yes No

Clear

JAS Diagnostics - 00817274022771 Catalog Number : AMY2-P1L

Device Description : AMYLASE Powder PALS (1 x1L)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022788 Catalog Number : MIA2-20

Device Description : Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : DCF

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022795 Catalog Number : MIAC2-7

Device Description : Microalbumin Control Kit (L1 & L2)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : DCF

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022801 Catalog Number : MIAS-1

Device Description : Microalbumin Multi-Calibrator (Levels A-F)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022818 Catalog Number : MICS-15

Device Description : Microprotein Standard

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022825 Catalog Number : MICS-10

Device Description : Microprotein Standard (1 x 10 mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022832 Catalog Number : GLU2-125

Device Description : GLUCOSE HEXOKINASE (2 x 125mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022849 Catalog Number : AMY2-BUL

Device Description : AMYLASE BULK LIQUID

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022856 Catalog Number : HDL4-250

Device Description : HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

Drew Scientific - 00817274022863 Catalog Number : 610600

Device Description : Hema-Clenz (1 x 30mL)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

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