FDA.reportPublic FDA data

EliA GBM Well

Primary DI
07333066014630
Brand
EliA GBM Well
Company
Phadia AB
Model
DECC055140
Catalog number
DECC055140
Device description
EliA GBM Well
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140225000
K173792000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140225000ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POPhadia US, Inc.2014-10-27MOB
K173792000EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia AB2018-03-13MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010670PackageGS12In Commercial Distribution
07333066014630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010670073330660106707333066010670
07333066014630073330660146307333066014630

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29
07333066024240EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024271EliA IgM Calibrator WellDECC066270DECC0662702026-01-29
07333066024325EliA RF IgM WellDECC067000DECC0670002026-01-29

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
07333066010670EliA GBM WellPhadia ABMVJ2016-09-23
05391516747943Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-19
00813545022938GBM P KDY Test(L) 48 SCIMEDX CORPORATIONMVJ2016-09-19
00813545022945GBM P KDY Test(L) 96 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