FDA.reportPublic FDA data

EliA Symphony Well

Primary DI
07333066014593
Brand
EliA Symphony Well
Company
Phadia AB
Model
DECC055080
Catalog number
DECC055080
Device description
EliA Symphony 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
LLLEXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010632PackageGS14In Commercial Distribution
07333066014593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010632073330660106327333066010632
07333066014593073330660145937333066014593

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection for multiple types of antinuclear antibodies (ANA) 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
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
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
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239027733ANA Screen IgG ELISA DRG International IncLLL2023-08-23
B3507202500Gold Standard Diagnostics Is-anti-SS-A ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGold Standard Diagnostics CorporationLLL2020-07-27
07333066016115EliA SymphonyS WellPhadia ABLLL2020-06-30
07333066016108EliA SymphonyS WellPhadia ABLLL2020-06-30
05391516746854Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-27
05391516746762Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
05391516746809Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
04048474035711ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
00404847435719ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
08426950595786QUANTA Flash® SS-B ReagentsINOVA DIAGNOSTICS, INC.LLL2017-08-28
04250289502924AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-10-27
10080196000616MedlineMEDLINE INDUSTRIES, INC.LLL2016-10-14
04250289500449AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2016-09-27
00816879020144Autostat II ENA-6 ScreenHYCOR BIOMEDICAL LLCLLL2016-09-26