FDA.report

Drew

Primary DI
00817274020166
Brand
Drew
Company
DREW SCIENTIFIC, INC.
Model
014-176
Device description
DS360 - HbA1c Control (3x 0.5mL L1, 3x 0.5mL L2, 1x 4mL Diluent, 1x 100mL Hemolyzer)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications

CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817274020166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020166008172740201668172740201660817274020166

GMDN Terms

TermDefinition
Prothrombin time (PT) IVD, kit, clotting, rapidA collection of reagents and other associated materials intended to be used for the semi-quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-305-324-2300Customersupport@erbadiagnostics.com

Regulatory Flags

DUNS number
144968104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817274022849JAS DiagnosticsAMY2-BULAMY2-BUL2016-10-11
00817274022856JAS DiagnosticsHDL4-250HDL4-2502016-10-11
00817274022825JAS DiagnosticsMICS-10MICS-102018-10-03
00817274022818JAS DiagnosticsMICS-15MICS-152018-09-25
00817274022788JAS DiagnosticsMIA2-20MIA2-202018-07-24
00817274022795JAS DiagnosticsMIAC2-7MIAC2-72018-07-24
00817274022801JAS DiagnosticsMIAS-1MIAS-12018-07-24
00817274022764JAS Diagnostics, incMAG2-125MAG2-1252018-07-19
00817274022771JAS DiagnosticsAMY2-P1LAMY2-P1L2018-07-19
00817274020173Drew Scientific014-3502016-09-09
00817274020258Drew ScientificCA-30EX2016-09-09
00817274020272Drew ScientificEXA-1825N2016-09-09
00817274020289Drew ScientificEXA-25H2016-09-09
00817274020296Drew ScientificEXA-25L2016-09-09
00817274020302Drew ScientificEXA-25N2016-09-09
00817274020319Drew ScientificEXA-3262016-09-09
00817274020326Drew ScientificEXA-339+2016-09-09
00817274020333Drew ScientificEXA-3462016-09-09

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