EliA Sample Diluent

Primary DI
07333066013206
Brand
EliA Sample Diluent
Company
Phadia AB
Model
83-0009-21
Catalog number
83-0009-21
Device description
EliA Sample Diluent
Published
2020-12-09
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
DBMANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181556000EliA M2 ImmunoassayPhadia AB2018-07-13DBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066020402PackageGS16In Commercial Distribution
07333066013206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066020402073330660204027333066020402
07333066013206073330660132067333066013206

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of plasma proteins in a clinical specimen.

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
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066020402EliA Sample DiluentPhadia ABDBM2020-12-09
07333066014333EliA M2 Positive Control 2500/5000Phadia ABDBM2020-12-09
00813545026608MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026615MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026622MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026639MeDiCaSCIMEDX CORPORATIONDBM2020-12-01
00813545026950MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026967MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026974MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
00813545026981MeDiCaSCIMEDX CORPORATIONDBM2020-11-04
08426950730101QUANTA Flash® M2 (MIT3) ReagentsINOVA DIAGNOSTICS, INC.DBM2018-01-26
00845714002502Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DBM2017-09-07
00845714002526Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DBM2017-09-07
04049016027157Anti-M2-3E ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124887EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124894EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
07333066014852EliA M2 WellPhadia ABDBM2016-09-23
07333066010908EliA M2 WellPhadia ABDBM2016-09-23
05391516743839Trinity BiotechCLARK LABORATORIES, INC.DBM2016-09-22
00813545022273MA(RK)48 Test(L) SCIMEDX CORPORATIONDBM2016-09-19
00813545022297MA(RK)96 Test(L) SCIMEDX CORPORATIONDBM2016-09-19
00813545022303MA MS KDYTest(L) 48 TestSCIMEDX CORPORATIONDBM2016-09-19
00813545022310MA MS KDY Test(L) 96 TestSCIMEDX CORPORATIONDBM2016-09-19
00813545020279R. KDY Pack 8 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020286M. KDY Pack 4 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020293R. KDY Pack 4 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020309M. KDY Pack 8 WELLSCIMEDX CORPORATIONDBM2016-09-13
00847817016257KallestadBIO-RAD LABORATORIES, INC.DBM2016-09-12
00847865001205KallestadBio-RAD Laboratories, Inc.DBM2016-09-12
00847865001588KallestadBio-RAD Laboratories, Inc.DBM2016-09-12