Gastrin-17 Advanced

Primary DI
06419587010359
Brand
Gastrin-17 Advanced
Company
Biohit Oyj
Model
601035
Device description
Gastrin-17 Advanced test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human gastrin-17 (G-17) from EDTA plasma or serum samples. The test is intended to aid in diagnosing atrophic gastritis (AG) from patients with Helicobacter pylori infection or at risk to develop malignant cellular changes in stomach mucosa. In addition, the test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa as G-17 is a direct biomarker of antral structure and function, and an indirect biomarker of gastric corpus. Furthermore, Gastrin-17 Advanced test is intended for screening and monitoring the acid output of the stomach. The test can be conducted either manually or automatically and is to be used by healthcare professionals.
Published
2022-12-08
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
06419587010359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06419587010359064195870103596419587010359

GMDN Terms#

Term, Definition table
TermDefinition
Gastrin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of gastrin in a clinical specimen, using an enzyme immunoassay (EIA) 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)].

Regulatory Flags#

DUNS number
459819199
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
07340058412015EURIA GastrinSvar Life Science ABCGC2016-08-12