Drew Scientific

GUDID 00817274020173

DS5 Pink Kit (300 test)

DREW SCIENTIFIC, INC.

Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817274020173
NIH Device Record Key5e56422f-fc3d-4a99-8e03-cd7848bd0fcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrew Scientific
Version Model Number014-350
Company DUNS144968104
Company NameDREW SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com
Phone1-305-324-2300
EmailCustomerservice@erbascientific.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817274020173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-09

On-Brand Devices [Drew Scientific]

00817274022573Hemolysis Reagent (2 x 125mL)
00817274022344Probe-Clenz (1 x 30 mL)
00817274022238DREW D3 ENZYMATIC CLEANER- Bulk Liquid
00817274020609Excell 3-Part Hematology Reagent Pack
00817274020593Gold Column Kit
00817274020517DS360 HbA1c Analyzer with accessories
00817274020487Differential Lyse (20L)
00817274020470EX Lyse (0.5L) Hematology Lysing Reagent
00817274020463EX -FLO Sheath (10L)
00817274020456EX ISO Diff Diluent 20L
00817274020449E-Z Clean (10L)
00817274020425DREW D3 LYTIC REAGENT - Bulk Liquid
00817274020401DREW D3 DILUENT - Bulk Liquid
00817274020395EX-TROL Normal (1 x 4.5mL) Control
00817274020388EX-TROL Low (1 x 4.5mL) Control
00817274020371EX-TROL High (1 x 4.5mL) Control
00817274020364Ex-Trol Plus Normal (1 x 3mL) Control
00817274020357Ex-Trol Plus Low (1 x 3mL) Control
00817274020340Ex-Trol Plus High (1 x 3mL) Control
00817274020333EX-TROL Tri-level (3 x 6 x 4.5mL) Control
00817274020326Control Kit, 3-Level (9 x 3ml)
00817274020319EX-TROL Tri-level (3 x 6 x 2.5mL) Control
00817274020302EX-TROL Normal (1 x 2.5mL) Control
00817274020296EX-TROL Low (1 x 2.5mL) Control
00817274020289EX-TROL High (1 x 2.5mL) Control
00817274020272EX-TROL Normal (18 x 2.5mL) Control
00817274020265Drew-3 Reagent Pack (360 test) DREW3-PAC
00817274020258EX-CAL (1 x 3mL)
00817274020234DS360 Reagent Test Kit (500 tests)
00817274020227DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer)
00817274020210DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)
00817274020203DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)
00817274020197Pink Kit Hemolyzer (440mL)
00817274020173DS5 Pink Kit (300 test)
00817274020159DS5 HbA1c Control (2-level) (2 x 3 x 0.5mL)
00817274020142DS5 HbA1c Control (2-level) (3x 0.5mL L1, 3x 0.5mL L2)
00817274020135Gold Kit 80-100 Test
00817274022863Hema-Clenz (1 x 30mL)
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