Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent
The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the…
The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
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 | Axis-Shield Diagnostics, Ltd., United Kingdom |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K083222 |
| Record published | 2016-07-01 |
| Record revised | 2025-05-30 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FHBC100/B08176 | In distribution | |
| FHRWR100 | 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
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Axis-Shield Diagnostics, Ltd. | 510(k) number | 2019-09-16 | Class II | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | 740 total | |
| Axis-Shield Diagnostics, Ltd. | 510(k) number | 2019-09-16 | Class II | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | 740 total | |
| Axis-Shield Diagnostics, Ltd. | 510(k) number | 2019-09-16 | Class II | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. | 740 total | |
| Horiba Instruments Incorporated | 510(k) number | 2015-04-03 | Class II | Unknown/Undetermined by firm | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesti | 13 | 2016-07-05 |
| Axis-Shield Diagnostics, Ltd. | 510(k) number | 2015-03-20 | Class II | Under Investigation by firm | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. | 52 kits + 75 kits Beckman Coulter Brand OUS | 2015-10-27 |
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.