FDA.reportPublic FDA data

Micro-Albumin

Primary DI
00198168683255
Brand
Micro-Albumin
Company
ORGENTEC Diagnostika GmbH
Model
ORG 5MA
Catalog number
ORG 5MA
Device description
Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only.The rate of albumin excertion in urine is an important control and prevention parameter for the evaluation of kidney function. If the glomerular filtration process is highly active, albumin excretion may be elevated without any kidney damage. Physical stress may also cause microalbuminuria.
Published
2023-12-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198168683255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198168683255001981686832551981686832550198168683255

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328133103
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
04260157080638ANA DETECTORG600ORG6002016-08-31
04260157080010ANTI-TGORG502ORG5022016-08-31
04260157080027ANTI-TPOORG503ORG5032016-08-31
04260157080034ENASCREENORG506ORG5062016-08-31
04260157080058ANTI-SS-AORG508ORG5082016-08-31
04260157080065ANTI-SS-BORG509ORG5092016-08-31
04260157080072ANTI-SMORG510ORG5102016-08-31
04260157080089ANTI-RPN/SMORG511ORG5112016-08-31
04260157080096ANTI-SCI-70ORG512ORG5122016-08-31
04260157080102ANTI-JO-1ORG513ORG5132016-08-31
04260157080126ANTI-CARDIOLIPIN IgG/IgMORG515ORG5152016-08-31
04260157080133ANTI-CARDIOLIPIN IgAORG515AORG515A2016-08-31
04260157080140ANTI-CARDIOLIPIN SCREENORG515SORG515S2016-08-31
04260157080171ANTI-PR3 (cANCA)ORG518ORG5182016-08-31
04260157080188ANTI-MPO (pANCA)ORG519ORG5192016-08-31
04260157080232RHEUMATOID FACTOR IgAORG522AORG522A2016-08-31
04260157080249RHEUMATOID FACTOR IgGORG522GORG522G2016-08-31
04260157080256RHEUMATOID FACTOR IgMORG522MORG522M2016-08-31
04260157080263RHEUMATOID FACTOR TOTALORG522TORG522T2016-08-31
04260157080683ANTI-dsDNAORG604ORG6042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIR2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIR2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10884389181942MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
40884389181943MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JIR2025-02-13
00850054026729QMedix™Diagnostic Automation, Inc.JIR2024-10-29
00850054026781QMedix™Diagnostic Automation, Inc.JIR2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIR2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JIR2024-05-03
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
00850049545921InstaTestDiagnostic Automation, Inc.JIR2023-06-14
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIR2023-06-08
17290017272471Minuteful - kidney testHEALTHY.IO LTDJIR2022-11-01
05055273206814TOTAL PROTEIN (UP)RANDOX LABORATORIES LIMITEDJIR2022-10-05
08806141302025One+Step ProteinDFI CO.,LTDJIR2022-10-03
10888277677791MedlineMEDLINE INDUSTRIES, INC.JIR2022-08-04
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIR2022-04-13
00894175000510 InstaTestDiagnostic Automation, Inc.JIR2021-09-23
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIR2021-09-16
00722066005255Rapid ResponseBTNX IncJIR2020-12-14
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JIR2020-09-30