FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021170
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
CHL2-BUL
Device description
CHLORIDE LIQUID BULK
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHJMercuric Thiocyanate, Colorimetry, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852169000CHLORIDE REAGENTPointe Scientific, Inc.,1985-08-21CHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021170008172740211708172740211700817274021170

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-305-324-2300Customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020715JAS DiagnosticsALP2-120R1U2016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486001334Teco Diagnostics Chloride Reagent SetTECO DIAGNOSTICSCHJ2023-07-25
10673486001341Teco Diagnostics Chloride Reagent Set TC MatrixTECO DIAGNOSTICSCHJ2023-07-25
EABA40000221Piccolo Electrolyte PanelABAXIS, INC.CHJ2016-09-23
EABA40000231Piccolo MetLyte 8 PanelABAXIS, INC.CHJ2016-09-23
EABA40000241Piccolo Basic Metabolic PanelABAXIS, INC.CHJ2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CHJ2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CHJ2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CHJ2016-09-23
EABA40000341Piccolo MetLyte Plus CRPABAXIS, INC.CHJ2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CHJ2016-09-23
00657498000632Chloride LiquiColor®STANBIO LABORATORY, L.P.CHJ2016-09-23