FDA.reportPublic FDA data

Gastrin - RIA

Primary DI
05400569004115
Brand
Gastrin - RIA
Company
Diasource Immunoassays S.A. SA
Model
KIPEMD302
Device description
Gastrin - RIA
Published
2020-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
05400569004115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569004115054005690041155400569004115

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
458777323
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400569000209IGF-1 ELISAKAP15812020-09-11
05400569000414KIP1131KIP11312020-09-11
05400569000520IGF-1-RIA-CTKIP15882020-09-11
05400569000407hGH-IRMAKIP10812020-01-15
05400569000117INS ELISAKAP12512020-01-10
05400569000087IGFBP-3 ElisaKAP11712020-01-09
05400569000346ANDROSTENEDIONE-RIA-CTKIP04512020-10-05
05400569000452LHsp-IRMAKIP13112020-10-05
05400569000674Estrone-RIA-CTKIPI91002020-09-16
05400569000360E2 RIA CTKIP06292020-09-15
0540056900065011-DESOXYCORTISOL-RIA-CTKIPI200002020-09-15
05400569000049C-PEP-EASIAKPA04012020-09-14
05400569000377FSH IRMAKIP08412020-09-14
05400569000865Androstenedione-ELISAKAPD32652020-09-14
05400569000490PROG-RIA-CTKIP14582020-09-11
05400569001411Trypsin-RIAKIPCE072020-01-29
05400569000322C-PEP II-RIA-CTKIP04092020-01-15
05400569000353DHEA-S-RIA-CTKIP04812020-01-15
05400569000438INS-IRMAKIP1251/KIP12542020-01-15
0540056900047617OHP RIA CTKIP14092020-01-15

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
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
07340058412015EURIA GastrinSvar Life Science ABCGC2016-08-12