Elecsys hGH CalSet
Elecsys hGH CalSet is a laboratory calibrator for the quantitative Elecsys human growth hormone assay on Elecsys and cobas e immunoassay analysers. It provides two concentration levels for…
Elecsys hGH CalSet is a laboratory calibrator for the quantitative Elecsys human growth hormone assay on Elecsys and cobas e immunoassay analysers. It provides two concentration levels for calibrating that assay.
The material contains human growth hormone in a human serum matrix. During manufacture, the hormone is added to reach the required concentration levels. The calibrators are supplied freeze-dried and require reconstitution with water before use.
Reconstitution
Each calibrator is reconstituted with exactly one millilitre of distilled or deionized water. It is left closed for 15 minutes and then mixed carefully, avoiding foam. Unopened material is stored at 2 to 8 degrees Celsius until expiry.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K103221 |
| Record published | 2016-09-20 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5390133190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Laboratories | 15 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
Showing 12 of 391. All products under Calibrator, Secondary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170938 | 2017-04-26 |
| K152526 | 2015-10-02 |
| K143342 | 2014-12-19 |
| K142021 | 2014-08-12 |
| K140112 | 2014-06-06 |
| K103221 | 2010-12-23 |
| K060754 | 2006-04-18 |
| K052982 | 2005-10-28 |
| K052193 | 2005-10-03 |
| K052002 | 2005-08-22 |
| K050231 | 2005-07-06 |
| K043095 | 2004-11-23 |
| K042490 | 2004-09-30 |
| K031299 | 2003-05-12 |
| K012399 | 2001-08-24 |
| K003411 | 2001-03-01 |
| K003409 | 2001-01-26 |
| K992981 | 1999-09-24 |
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.