FDA.report

JAS Diagnostics

Primary DI
00817274021132
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
CAL1-5
Device description
CHEMISTRY CALIBRATOR KIT (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
JITCalibrator, Secondary

Product Code Classifications

CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817274021132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021132008172740211328172740211320817274021132

GMDN Terms

TermDefinition
Chloride (Cl-) IVD, calibratorA material which is used to establish known points of reference for 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336222331ISE Internal Standard Gen.2 conc.Roche Diagnostics GmbHJIT2026-03-20
04015630926091Testosterone II CalSet IIRoche Diagnostics GmbHJIT2026-02-23
04560189213418ST AIA-PACK PROG II CALIBRATOR SETTOSOH CORPORATIONJIT2026-02-02
00817089023222DiazymeDIAZYME LABORATORIES, INC.JIT2026-01-21
04562185403060HbA1c Calibrator Set (S)TOSOH CORPORATIONJIT2026-01-05
00380740189822AlinityAbbott GmbHJIT2026-01-01
00380740189846ARCHITECTAbbott GmbHJIT2026-01-01
00380740168742AlinityAbbott Ireland DiagnosticsJIT2025-12-11
07613336216958CalSet Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJIT2025-11-18
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399671CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399725CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185400407CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
05711435000163ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SJIT2025-08-28
00630414320304Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
07613336180822CalSet Cortisol III UrineRoche Diagnostics GmbHJIT2025-07-24
15099590763633Access Syphilis CalibratorsBeckman Coulter, Inc.JIT2025-05-07
04987595300011PATHFAST Sample Diluent 1PHC CORPORATIONJIT2025-04-18
04987595300028PATHFAST Sample Diluent 2PHC CORPORATIONJIT2025-04-18
04015630924288sFlT-1 CalSetRoche Diagnostics GmbHJIT2025-04-07
04015630925407CalSet PlGFRoche Diagnostics GmbHJIT2025-04-07
05055845400534Alere NT-proBNP for Alinity Calibrator KitAXIS-SHIELD DIAGNOSTICS LIMITEDJIT2025-02-27
08058056685285ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
08058056685315ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
20758750034625VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
20758750035066VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
08430793243001HEMOSIL RIVAROXABAN CALIBRATORSINSTRUMENTATION LABORATORY COMPANYJIT2024-07-22
20758750034915VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25