FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274022795
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
MIAC2-7
Catalog number
MIAC2-7
Device description
Microalbumin Control Kit (L1 & L2)
Published
2018-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DCFAlbumin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCFAlbumin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274022795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274022795008172740227958172740227950817274022795

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume14Milliliter

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
1-305-324-2300customerservice@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
00630414611099Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
00630414320298Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
04050598163300Albumin ELISAImmundiagnostik AGDCF2023-06-21
03610230007235Yumizen C1200 Albumin U/CSFHORIBA ABX SASDCF2020-09-14
00628063401116MicroalbuminSEKISUI DIAGNOSTICS, LLCDCF2019-10-02
06970291985222Microalbuminuria Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DCF2019-03-07
00386100002213UALB Reagent KitMEDICA CORPORATIONDCF2019-02-14
00817274022788JAS DiagnosticsDREW SCIENTIFIC, INC.DCF2018-07-24
B24224MABHUE010Microalbumin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DCF2018-01-16
03610230008232ABX Pentra Micro ALB 2 CalHORIBA ABX SASDCF2017-07-07
03610230008225ABX Pentra Micro ALBUMIN 2 CPHORIBA ABX SASDCF2017-06-27
05051700018432Optilite Low Level Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2017-06-07
15099590010645AUBECKMAN COULTER IRELAND INC.DCF2016-09-24
15099590020422AUBeckman Coulter, Inc.DCF2016-09-24
15099590670108AUBeckman Coulter, Inc.DCF2016-09-24
B1761140Antiserum to Human AlbuminKENT LABORATORIES INCDCF2016-09-24
05051700010689Human Albumin NL BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700016193Human Albumin CSF Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017916Optilite Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017923Human Microalbumin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
00842768005312Dimension® Flex® reagent cartridge MALBSiemens Healthcare Diagnostics Inc.DCF2016-09-24
00842768006098DImension Vista® sALB Flex® reagent cartridgeSpecialty AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768006203DImension Vista® Microalbumin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038013N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038020N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00657498000434Albumin LiquiColor®STANBIO LABORATORY, L.P.DCF2016-09-23
00657498001516Sirrus® Albumin LiquiColor®STANBIO LABORATORY, L.P.DCF2016-09-23
04015630924899Tinaquant Albumin Gen2Roche Diagnostics GmbHDCF2016-09-20
00628063400812MICROALBUMIN AssaySEKISUI DIAGNOSTICS, LLCDCF2016-09-20
00816426020139K-ASSAY® Microalbumin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDCF2016-09-16