5-PLASMA Bivalirudin AMR Verification Kit
The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify…
The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify bivalirudin activity or concentration in human plasma. The kit consists of five levels of plasma-based materials containing defined concentrations of bivalirudin, covering the clinically relevant measurement range of the associated assay. The kit is designed for laboratory use to verify that a coagulation analyzer or assay method performs accurately and linearly across its claimed analytical measuring range for bivalirudin. It is not intended for direct diagnostic use or patient result reporting.
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 | 5-DIAGNOSTICS, Switzerland |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-04-20 |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5D-45905 | 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
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 |
|---|---|---|---|---|---|---|
| Aniara Diagnostica, LLC | UDI-DI | 2026-07-01 | Class II | Process control | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. | 4 units |
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.