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) Products, Red-Cell Lysing Products (GGK) (3) Bromcresol Green Dye-Binding, Albumin (CIX) (2) Detergent (JCB) (1) Diluent, Blood Cell (GIF) (1)

Premarket Exempt

No Yes

Clear

Drew Scientific - 00817274020463 Catalog Number :

Device Description : EX -FLO Sheath (10L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GIF

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020470 Catalog Number :

Device Description : EX Lyse (0.5L) Hematology Lysing Reagent

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020487 Catalog Number : RA-9020

Device Description : Differential Lyse (20L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020517 Catalog Number :

Device Description : DS360 HbA1c Analyzer with accessories

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew - 00817274020524 Catalog Number :

Device Description : DS360 HbA1c Analyzer (Instrument only)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020593 Catalog Number :

Device Description : Gold Column Kit

Device Class : 2

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : LCP

Prescription Use : No

Device Count : 1

Drew Scientific - 00817274020609 Catalog Number :

Device Description : Excell 3-Part Hematology Reagent Pack

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : GGK

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274020616 Catalog Number :

Device Description : ABS OLYMPUS WASH SOLUTION - CONCENTRATED (6x 2L)

Device Class : 1

Duns Number: 144968104

Premarket Exempt : Yes

Product Code : JCB

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274020623 Catalog Number :

Device Description : ALBUMIN (5 x 40mL)

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CIX

Prescription Use : No

Device Count : 1

JAS Diagnostics - 00817274020630 Catalog Number :

Device Description : ALBUMIN REAGENT 1 X 1L

Device Class : 2

Duns Number: 144968104

Premarket Exempt : No

Product Code : CIX

Prescription Use : No

Device Count : 1

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