FDA.reportPublic FDA data

EUROLINE ENA Profile 9 Ag (IgG)

Primary DI
04049016124900
Brand
EUROLINE ENA Profile 9 Ag (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
DL 1590-1601-9 G
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LKOAnti-Rnp Antibody, Antigen And Control
LKPAnti-Sm Antibody, Antigen And Control
LLLExtractable Antinuclear Antibody, Antigen And Control
MQAAnti-Ribosomal P Antibodies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2
LKPAnti-Sm Antibody, Antigen And ControlImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
MQAAnti-Ribosomal P AntibodiesImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140224000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140224000EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)Euroimmun US2014-12-09LKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016124900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016124900040490161249004049016124900

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen auto-antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple auto-antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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
00850054026569QMedix™Diagnostic Automation, Inc.LJM2024-04-23
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKP2023-12-14
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKO2023-12-14
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.MQA2023-12-14
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
00840239035769Anti-SS-B ELISADRG International IncLJM2023-10-09
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474041170ANA Detect ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
04048474027747DNA (ds) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027792ENA Screen (entractable nuclear antigen) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027808ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027822SSA (Ro) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027839SSB (La) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027846Sm IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027853Sm RNP IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027860Scl-70 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027877Jo-1 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474035803Anti-Scl-70 ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
00084023903579Anti-SS-B ELISA DRG International IncLJM2023-08-25
00840239035776Anti-Sm ELISADRG International IncLJM2023-08-25
00840239035783Anti-RNP/Sm ELISA DRG International IncLJM2023-08-25
00840239035806Anti-Scl-70 ELISADRG International IncLJM2023-08-25
00840239035813Anti-Jo-1 ELISADRG International IncLJM2023-08-25
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239041173ANA Detect ELISADRG International IncLJM2023-08-25
00840239027870Jo-1 IgG ELISADRG International IncLJM2023-08-24
00840239035622ANA-8-Screen ELISADRG International IncLJM2023-08-24
00840239035639ANA-8-Profile ELISADRG International IncLJM2023-08-24