FDA.report

JAS Diagnostics

Primary DI
00817274021149
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
DG-CON1-5
Device description
CHEMISTRY CONTROL LEVEL 1 (10x 5mL)
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817274021149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021149008172740211498172740211490817274021149

GMDN Terms

TermDefinition
Chloride (Cl-) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of chloride (Cl-) in a clinical specimen.

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817274022863Drew Scientific6106006106002021-08-20
00817274022832JAS DiagnosticsGLU2-125GLU2-1252018-11-06
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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