Gastrin-17 Advanced
Basic Information
- Brand Name
- Gastrin-17 Advanced
- Primary DI
- 06419587010359
- Version / Model
- 601035
- Company Name
- Biohit Oyj
- Labeler DUNS
- 459819199
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- b837329e-6a95-4710-8b77-980649e1519a
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CGC | Radioimmunoassay, Gastrin | Clinical Chemistry | 862.1325 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54190 | 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)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06419587010359 | GS1 |