Exact Diagnostics
HIV-1 Analytical Measurement Range Panel
1manufacturer
30catalogue 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 | Exact Diagnostics, United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2021-04-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -20 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CMVP200 | In distribution | |
| HBVAMR | In distribution | |
| HIVP100 | In distribution | |
| HBVH202 | In distribution | |
| EBVP100 | In distribution | |
| CMVL201 | In distribution | |
| HIVP200 | In distribution | |
| HCVH202 | In distribution | |
| B19P100 | In distribution | |
| BKVP100 | In distribution | |
| HV6AP100 | In distribution | |
| HCVP100 | In distribution | |
| CMVH202 | In distribution | |
| HIVH202 | In distribution | |
| VZVP100 | In distribution | |
| HBVP200 | In distribution | |
| HCVP200 | In distribution | |
| HCVL201 | In distribution | |
| HCVAMR | In distribution | |
| HV6BP100 | In distribution | |
| HIVL201 | In distribution | |
| HSV1P100 | In distribution | |
| CMVP100 | In distribution | |
| HBVP100 | In distribution | |
| JCVP100 | In distribution | |
| HSV2P100 | In distribution | |
| HIVAMR | In distribution | |
| HBVL201 | In distribution | |
| ADVP100 | In distribution | |
| ZKVP100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| 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 |
| 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.