FDA.reportPublic FDA data

Anti-nRNP/Sm ELISA (IgG)

Primary DI
04049016027010
Brand
Anti-nRNP/Sm ELISA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EA 1591-9601 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
LKOAnti-Rnp Antibody, Antigen And Control

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123261000EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun US2013-06-12LKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016027010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016027010040490160270104049016027010

GMDN Terms#

Term, Definition table
TermDefinition
Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) 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
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKO2023-12-14
00816879020328Autostat II Anti-Sm/RNPHYCOR BIOMEDICAL LLCLKO2016-09-26
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
07333066014623EliA RNP70 WellPhadia ABLKO2016-09-23
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