Liquid Ranbut (RBT)
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.
2manufacturers in China registered for this device type
2catalogue 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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JMK |
| Device type | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1380 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-23 |
| Record revised | 2023-07-06 (version 2) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RB8378 | In distribution | |
| RB4067 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| PTS Panels® Ketones Test Strips | Polymer Technology Systems | 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.