FDA.reportPublic FDA data

GBM P KDY Test(L) 96

Primary DI
00813545022945
Brand
GBM P KDY Test(L) 96
Company
SCIMEDX CORPORATION
Model
5696L
Catalog number
5696L
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545022945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545022945008135450229458135450229450813545022945

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533002028Glomerular Basement Membrane (Primate Kidney)ZEUS SCIENTIFIC, INC.MVJ2025-10-17
04049016108832EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108849EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108856EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108863EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016119920EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135883EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135890EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135968EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
00816879020137Autostat II Anti-GBMHYCOR BIOMEDICAL LLCMVJ2016-09-26
07333066014630EliA GBM WellPhadia ABMVJ2016-09-23
07333066010670EliA GBM WellPhadia ABMVJ2016-09-23
05391516747943Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-19
00813545022938GBM P KDY Test(L) 48 SCIMEDX CORPORATIONMVJ2016-09-19
05391516747585Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748001Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748018Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
00813545020583P KDY Pack 4 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00813545020606P KDY Pack 8 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00847865000536BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002387BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002394BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865010955BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865011082BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
08426950454533QUANTA Lite® GBM ELISA INOVA DIAGNOSTICS, INC.MVJ2016-08-31
08426950584650QUANTA Flash® GBM ReagentsINOVA DIAGNOSTICS, INC.MVJ2016-08-31
08426950595823QUANTA Lite® GBM ELISA Bulk PackINOVA DIAGNOSTICS, INC.MVJ2016-08-31