EliA Sample Diluent

Primary DI
07333066020402
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
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07333066013206EliA 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
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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
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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
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00847865001588KallestadBio-RAD Laboratories, Inc.DBM2016-09-12