FDA.reportPublic FDA data

ANTI-MCV

Primary DI
04260157080539
Brand
ANTI-MCV
Company
ORGENTEC Diagnostika GmbH
Model
ORG548
Catalog number
ORG548
Device description
Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.
Published
2016-12-08
Public version status
Update
Distribution status
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
OQZAnti-Mutated Citrullinated Vimentin Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQZAnti-Mutated Citrullinated Vimentin IggImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157080539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157080539042601570805394260157080539

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