FDA.reportPublic FDA data

Anti-PLA2R IFA

Primary DI
04049016095781
Brand
Anti-PLA2R IFA
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FA 1254-1005-50
Published
2016-10-10
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
PGVAnti-Phospholipase A2 Receptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGVAnti-Phospholipase A2 ReceptorMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140002000EUROIMMUN ANTI-PLA2R IFAEuroimmun US2014-05-29PGV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016095781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016095781040490160957814049016095781

GMDN Terms#

Term, Definition table
TermDefinition
Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative detection of antibodies to the phospholipase A2 receptor (PLA2R) in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagnosis of the kidney disease known as primary membranous glomerulonephritis.

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
04049016138501Anti-PLA2R IFAEUROIMMUN Medizinische Labordiagnostika AGPGV2019-06-07
04049016095774Anti-PLA2R IFAEUROIMMUN Medizinische Labordiagnostika AGPGV2016-10-10
04049016095798Anti-PLA2R IFAEUROIMMUN Medizinische Labordiagnostika AGPGV2016-10-10
04049016095804Anti-PLA2R IFAEUROIMMUN Medizinische Labordiagnostika AGPGV2016-10-10
04049016102748Anti-PLA2R ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGPGV2016-09-24