Architect
ARCHITECT STAT High Sensitivity Troponin-I Calibrators
1manufacturer
24catalogue numbers in this listing
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 | Abbott Ireland, Ireland |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-09 |
| Record revised | 2024-04-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7K62-10 | In distribution | |
| 2P40-01 | In distribution | |
| 07K6402 | In distribution | |
| 7K63-25 | In distribution | |
| 7K75-01 | In distribution | |
| 1P74-12 | In distribution | |
| 7K77-01 | In distribution | |
| 7K63-10 | In distribution | |
| 5P02-02 | In distribution | |
| 1P74-27 | In distribution | |
| 7K66-32 | In distribution | |
| 7K65-35 | In distribution | |
| 7K66-35 | In distribution | |
| 02R9801 | In distribution | |
| 7K77-10 | In distribution | |
| 7K76-10 | In distribution | |
| 7K76-01 | In distribution | |
| 7K61-12 | In distribution | |
| 7K66-02 | In distribution | |
| 7K64-50 | In distribution | |
| 5P02-25 | In distribution | |
| 7K64-01 | In distribution | |
| 07K6302 | In distribution | |
| 5P02-30 | 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 |
| 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 |
| Fluid Pack | Diamond Diagnostics Inc. | 5 |
Showing 12 of 391. All products under Calibrator, Secondary
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.