Micro-Albumin ORG 5MA

GUDID 00198168683255

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.

ORGENTEC Diagnostika GmbH

Albumin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00198168683255
NIH Device Record Key2657c810-19e6-478d-8359-095cf8117826
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro-Albumin
Version Model NumberORG 5MA
Catalog NumberORG 5MA
Company DUNS328133103
Company NameORGENTEC Diagnostika GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100198168683255 [Primary]

FDA Product Code

JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-22
Device Publish Date2023-12-14

Devices Manufactured by ORGENTEC Diagnostika GmbH

00198168683255 - Micro-Albumin2023-12-22Micro-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.
00198168683255 - Micro-Albumin2023-12-22 Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is in
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