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

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (2) Calibrator, Secondary (JIT) (2) Photometric Method, Magnesium (JGJ) (2) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Detergent (JCB) (1) Biuret (Colorimetric), Total Protein (CEK) (1) Azo Dye, Calcium (CJY) (1)

Premarket Exempt

Yes No

Clear

JAS Diagnostics - 00817274022375 Catalog Number : LIPS1-1

Device Description : LIPID CALIBRATOR (3x 1mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274022382 Catalog Number : DG-LIPS1-1

Device Description : DGLab HDL/LDL CHOLESTEROL CALIBRATOR (3x 1mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : JIT

Prescription Use : No

Device Count : 1

JAS Diagnostics, inc - 00817274022399 Catalog Number : MAG2-BUL

Device Description : Magnesium Arsenazo Bulk Liquid (20L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

JAS Diagnostics, inc - 00817274022405 Catalog Number : MAGS-BUL

Device Description : Magnesium Standard Liquid Bulk

Device Class : 1

Duns Number: 144968104

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022429 Catalog Number :

Device Description : ABS OLYMPUS WASH SOLUTION - CONCENTRATED (5 X 4L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274022436 Catalog Number : ALP2-BUL-R1

Device Description : Alkaline Phosphatase Bulk Liquid R1 10 L

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274022443 Catalog Number : ALP2-BUL-R2

Device Description : Alkaline Phosphatase Bulk Liquid R1 2.5 L

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274022450 Catalog Number : CAA2-1L

Device Description : Calcium Arsenazo Reagent(1 x 1L)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022467 Catalog Number : PHO2-1L

Device Description : Phosphorus Liquid Reagent (1 x 1L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

JAS Diagnostics - 00817274022474 Catalog Number : TPT2-1L

Device Description : TOTAL PROTEIN LIQUID REAGENT (1 x 1L)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : Yes

Device Count : 1

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