FDA.reportPublic FDA data

ANTI-dsDNA

Primary DI
04260157080683
Brand
ANTI-dsDNA
Company
ORGENTEC Diagnostika GmbH
Model
ORG604
Catalog number
ORG604
Device description
Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953671000ORGEN TEC ANTI-DSDNA ELISA ASSAYOrgentec1995-11-09LRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157080683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157080683042601570806834260157080683

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) 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

Contacts#

Phone, Email table
PhoneEmail
+49061319258BARBARA.MANSI@ORGENTEC.COM

Regulatory Flags#

DUNS number
328133103
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260157080638ANA DETECTORG600ORG6002016-08-31
00198168683255Micro-AlbuminORG 5MAORG 5MA2023-12-14
04260157080010ANTI-TGORG502ORG5022016-08-31
04260157080027ANTI-TPOORG503ORG5032016-08-31
04260157080034ENASCREENORG506ORG5062016-08-31
04260157080058ANTI-SS-AORG508ORG5082016-08-31
04260157080065ANTI-SS-BORG509ORG5092016-08-31
04260157080072ANTI-SMORG510ORG5102016-08-31
04260157080089ANTI-RPN/SMORG511ORG5112016-08-31
04260157080096ANTI-SCI-70ORG512ORG5122016-08-31
04260157080102ANTI-JO-1ORG513ORG5132016-08-31
04260157080126ANTI-CARDIOLIPIN IgG/IgMORG515ORG5152016-08-31
04260157080133ANTI-CARDIOLIPIN IgAORG515AORG515A2016-08-31
04260157080140ANTI-CARDIOLIPIN SCREENORG515SORG515S2016-08-31
04260157080171ANTI-PR3 (cANCA)ORG518ORG5182016-08-31
04260157080188ANTI-MPO (pANCA)ORG519ORG5192016-08-31
04260157080232RHEUMATOID FACTOR IgAORG522AORG522A2016-08-31
04260157080249RHEUMATOID FACTOR IgGORG522GORG522G2016-08-31
04260157080256RHEUMATOID FACTOR IgMORG522MORG522M2016-08-31
04260157080263RHEUMATOID FACTOR TOTALORG522TORG522T2016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840239034380Anti-dsDNA IgG ELISADRG International IncLRM2023-08-24
00840239035646Anti-dsDNA IgM ELISADRG International IncLRM2023-08-24
00840239035653Anti-dsDNA IgA ELISADRG International IncLRM2023-08-24
00840239035660Anti-dsDNA Screen ELISADRG International IncLRM2023-08-24
B3507207000Gold Standard Diagnostics Is-anti-dsDNA ELISA Test KitGold Standard Diagnostics CorporationLRM2022-12-02
04048474034387Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035643Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035650Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035667Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847434385Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435641Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435658Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435665Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
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00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-10-27
00816879020014Autostat II Anti-ds-DNAHYCOR BIOMEDICAL LLCLRM2016-09-26
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