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JAS Diagnostics

Primary DI
00817274021897
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
MIC2-BUL
Device description
MICROPROTEIN REAGENT
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGPLowry (Colorimetric), Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGPLowry (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070757000MICROPROTEIN REAGENT SETPointe Scientific, Inc.,2007-12-04JGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021897008172740218978172740218970817274021897

GMDN Terms#

Term, Definition table
TermDefinition
Total microprotein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total microprotein in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
06971674868040BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674868392BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869252BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869269BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869276BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869283BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869290BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
10758750000623VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2020-05-29
10758750000630VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2020-05-29
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalCLEARCHEM DIAGNOSTICS INC.JGP2018-06-08
00811727011916Pointe Scientific, Inc. MicroproteinHORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
00811727011923Pointe Scientific, Inc. Microprotein StandardHORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
00811727012753Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
10758750000593VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2016-08-10