Biobase
8 catalogue numbers from R1:40mL×2 R2:20mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | CED |
| Device type | 5-Amp-Phosphate Release (Colorimetric Test), 5′-Nucleotidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1520 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-22 |
| Record revised | 2024-04-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1:40mL×2 R2:20mL×2 | In distribution | |
| R1:50mL×2 R2:25mL×2 | In distribution | |
| R1:20mL×1 R2:10mL×1 | In distribution | |
| R1:20mL×4 R2:10mL×4 | In distribution | |
| R1:50mL×2 R2:25mL×2 | In distribution | |
| R1:50mL×2 R2:25mL×2 | In distribution | |
| R1:50mL×2 R2:25mL×2 | In distribution | |
| Control:1mL×1 | In distribution |
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.