Elecsys Progesterone III CalSet
Elecsys Progesterone III CalSet is a two-level calibrator used with the quantitative Elecsys Progesterone III assay on Elecsys and cobas e immunoassay analysers. It supplies defined…
Elecsys Progesterone III CalSet is a two-level calibrator used with the quantitative Elecsys Progesterone III assay on Elecsys and cobas e immunoassay analysers. It supplies defined progesterone concentrations for setting the assay’s calibration response.
The material contains plant-derived progesterone in a human serum matrix and is supplied in lyophilised form. Each bottle is reconstituted with exactly 1 mL of distilled or deionised water and left closed for 15 minutes before careful mixing.
Calibration Aliquots
Reconstituted material is transferred into labelled CalSet vials, with one calibration procedure per aliquot. The two target concentrations are 0.080 ng/mL and 53 ng/mL.
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) | K152526 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 7092547190 | 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.