QwikCheck Vitality Kit
Catalogue number QwikCheck Vitality Kit- 5 Vials, listed by M.E.S. Medical Electronic Systems Ltd., under Eosin Y. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Shenzhen Dakewe BIO-Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | M.E.S. Medical Electronic Systems Ltd. |
|---|---|
| FDA product code | HYB |
| Device type | Eosin Y |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Premarket notification | Exempt |
| Record published | 2023-06-08 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QwikCheck Vitality Kit- 5 Vials | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 14 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 5 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
| Edgar Degas Eosin | Biocare Medical, LLC | 1 |
| Rubens Eosin-Phloxine | Biocare Medical, LLC | 1 |
| BioSci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 1 |
| Ventana HE 600 Eosin | Ventana Medical Systems, Inc. | 1 |
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.