Architect
ARCHITECT Active-B12 (Holotranscobalamin) Calibrators
1manufacturer
26catalogue 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 Medical, United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153730 |
| Record published | 2016-09-09 |
| Record revised | 2025-07-28 (version 7) |
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 | Handling environment temperature up to -0.1 °C; Storage environment temperature up to -10 °C |
| Distribution end date | 2022-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2P13-10 | In distribution | |
| 08K2803 | In distribution | |
| 08K2602 | In distribution | |
| 3P24-01 | In distribution | |
| 3P24-25 | In distribution | |
| 02K4402 | In distribution | |
| 5P03-27 | In distribution | |
| 8D06-04 | In distribution | |
| 1L71-10 | In distribution | |
| 1L71-01 | In distribution | |
| 08K2702 | In distribution | |
| 6E57-03 | In distribution | |
| 02K4502 | In distribution | |
| 5P03-01 | In distribution | |
| 08K2804 | In distribution | |
| 2P54-01 | In distribution | |
| 03L5302 | In distribution | |
| 08K4103 | In distribution | |
| 08K2504 | In distribution | |
| 3P24-02 | In distribution | |
| 8K27-10 | Withdrawn | |
| 8K26-01 | Withdrawn | |
| 3L52-27 | Withdrawn | |
| 8K26-10 | Withdrawn | |
| 8K25-03 | Withdrawn | |
| 4P72-35 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| 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 |
| Fluid Pack | Diamond Diagnostics Inc. | 5 |
Showing 12 of 391. All products under Calibrator, Secondary
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Laboratories | UDI-DI | 2019-05-24 | Class III | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. | 5,483 units | 2021-04-01 |
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.