FDA.reportPublic FDA data

EliA RNP70 Well

Primary DI
07333066014623
Brand
EliA RNP70 Well
Company
Phadia AB
Model
DECC055110
Catalog number
DECC055110
Device description
EliA RNP70 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
LKOANTI-RNP ANTIBODY, ANTIGEN AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010663PackageGS12In Commercial Distribution
07333066014623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010663073330660106637333066010663
07333066014623073330660146237333066014623

GMDN Terms#

Term, Definition table
TermDefinition
U1-RNP 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 U1-RNP antigen (anti-U1-RNP) 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
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
07333066024325EliA RF IgM WellDECC067000DECC0670002026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKO2023-12-14
00816879020328Autostat II Anti-Sm/RNPHYCOR BIOMEDICAL LLCLKO2016-09-26
04049016027010Anti-nRNP/Sm ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
07333066010663EliA RNP70 WellPhadia ABLKO2016-09-23
00847817022456Autoimmune EIABIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865002448BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865002721BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865012331BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
08426950595151QUANTA Flash® RNP ReagentsINOVA DIAGNOSTICS, INC.LKO2016-08-31
07340058410004DIASTAT anti-Ro (SS-A)Svar Life Science ABLKO2016-08-12
07340058410011DIASTAT anti-La (SS-B)Svar Life Science ABLKO2016-08-12