FDA.reportPublic FDA data

EURIA Gastrin

Primary DI
07340058412015
Brand
EURIA Gastrin
Company
Svar Life Science AB
Model
MD302
Catalog number
MD302
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CGCRadioimmunoassay, Gastrin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGCRadioimmunoassay, GastrinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058412015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058412015073400584120157340058412015

GMDN Terms#

Term, Definition table
TermDefinition
Gastrin IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of gastrin in a clinical specimen, using a radioimmunoassay method. It is used to aid in the investigation and treatment of disorders associated with abnormal gastrin production [e.g., recurrent peptic ulcers, gastrin-producing tumours (gastrinomas) and Zollinger-Ellison syndrome (ZES)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
559894501
Device count
1
Premarket exempt
true
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
07340058410004DIASTAT anti-Ro (SS-A)FARO300FARO3002016-08-12
07340058410011DIASTAT anti-La (SS-B)FALA200FALA2002016-08-12
07340058410028DIASTAT anti-Sm/RNPFRNP200FRNP2002016-08-12
07340058410035DIASTAT anti-dsDNAFDNA100FDNA1002016-08-12
07340058410059DIASTST anti-SmFASM200FASM2002016-08-12
07340058410110DIASTAT anti-thyroglobulinFATG200FATG2002016-08-12
07340058410134DIASTAT anti-Thyroid PeroxidaseFTPO300FTPO3002016-08-08
07340058410141DIASTAT anti-B2 Glycoprotein-1 IgGFBGP200FBGP2002016-08-12
07340058410158DIASTAT anti-B2-Glycoprotein-1 IgMFBGP100FBGP1002016-08-12
07340058410196DIASTAT anti-Cardiolipin IgGFCAR100GFCAR100G2016-08-12
07340058410233DIASTAT anti-Cardiolipin IgMFCAR100MFCAR100M2016-08-12
07340058410400DIASTAT total anti-CardiolipinFCAR100TFCAR100T2016-08-12
07340058410417DIASTAT anti-MitochondrialFMIT200FMIT2002016-08-12
07340058410431CCPointCCPoint20USCCPoint20US2016-09-09
07340058410462DIASTAT anti-SCL-70FSCL200FSCL2002016-08-12
07340058410479DIASTAT anti-Jo-1FAJO200FAJO2002016-08-12
07340058410486DIASTAT ANAFANA200FANA2002016-08-12
07340058410493DIASTAT ENA Single Well ScreenFSWS200FSWS2002016-08-12
07340058410509DIASTAT ENA ProfileFAID200FAID2002016-08-12
07340058410615EDIA anti-CCPFCCP100FCCP1002016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817830023006MP Biomedicals LLCMp Biomedicals, LLCCGC2023-08-02
00817830023136MP Biomedicals LLCMp Biomedicals, LLCCGC2023-08-02
06419587010359Gastrin-17 AdvancedBiohit OyjCGC2022-12-08
00630414961521IMMULITE® 2000 Systems GAS GastrinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGC2020-09-24
05400569004115Gastrin - RIADiasource Immunoassays S.A. SACGC2020-01-09
00630414953793IMMULITE®/IMMULITE® 1000 Systems GAS Gastrin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGC2016-09-24
00630414964034IMMULITE®/IMMULITE® 1000 Systems GAS GastrinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGC2016-09-24