IDS-iSYS Insulin Like Growth Factor-I (IGF-1) Calibration Verifiers
The IDS-iSYS IGF-I Calibration Verifier checks calibration of the IDS-iSYS IGF-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer. It is a calibration verification material for use…
The IDS-iSYS IGF-I Calibration Verifier checks calibration of the IDS-iSYS IGF-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer. It is a calibration verification material for use with that specific laboratory assay.
The formulation contains IGF-I peptide in a buffered protein matrix with bovine serum albumin and sodium azide preservative. The resulting solution is lyophilized.
Use After Reconstitution
The reconstituted verifier is stable for up to 2.5 hours on the analyzer. It is not intended to be stored onboard the analyzer between uses.
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Immunodiagnostic Systems Ltd., United Kingdom |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K122141 |
| Record published | 2016-04-01 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store upon receipt at 2 to 8 degrees celsius; Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-3935 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161082 | 2016-05-17 |
| K143324 | 2015-03-30 |
| K122141 | 2012-08-07 |
| K111938 | 2012-02-14 |
| K111650 | 2011-09-06 |
| K110412 | 2011-03-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.