FDA.reportPublic FDA data

ANA DETECT

Primary DI
04260157080638
Brand
ANA DETECT
Company
ORGENTEC Diagnostika GmbH
Model
ORG600
Catalog number
ORG600
Device description
ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases.
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
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030929000ANA DETECTOrgentec Diagnostika GmbH2003-05-02LJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157080638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157080638042601570806384260157080638

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) 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 antinuclear antibodies (ANA) 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
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
04260157080683ANTI-dsDNAORG604ORG6042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026569QMedix™Diagnostic Automation, Inc.LJM2024-04-23
00840239035769Anti-SS-B ELISADRG International IncLJM2023-10-09
04048474041170ANA Detect ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-31
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
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
00840239035738Anti-SS-A (Ro) ELISADRG International IncLJM2023-08-24
00840239027740DNA (ds) IgG ELISADRG International IncLJM2023-08-23
00840239027795ENA Screen (entractable nuclear antigen) ELISA DRG International IncLJM2023-08-23
00840239027801ENA-6-Profile ELISADRG International IncLJM2023-08-23
00840239027825SSA (Ro) ELISA DRG International IncLJM2023-08-23
00840239027832SSB (La) IgG ELISADRG International IncLJM2023-08-23
00840239027849Sm IgG ELISADRG International IncLJM2023-08-23
00840239027856Sm RNP IgG ELISADRG International IncLJM2023-08-23