iSED
Catalogue number 112-00101, listed by Alcor Scientific LLC, United States, under Device, Automated Sedimentation Rate. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Alcor Scientific LLC, United States |
|---|---|
| FDA product code | GKB |
| Device type | Device, Automated Sedimentation Rate |
| Device class | Class 1 |
| Regulation | 21 CFR 864.5800 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-09 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 112-00101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Starrsed | Mechatronics USA | 16 |
| Vision ESR Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 12 |
| Excyte® | ELITechGroup B.V. | 4 |
| Latex Controls | Alifax SRL | 4 |
| Latex EQE (2 Test) | Alifax SRL | 3 |
| Latex Calibrators | Alifax SRL | 2 |
| Starrsed Control | RR Mechatronics Manufacturing B.V. | 2 |
| Excyte® ESR Vacuum Tube, Carton | ELITechGroup Inc | 2 |
| ESR-Auto Plus | Streck LLC | 2 |
| Roller 20 | Alifax SRL | 2 |
| Sediplus® S 2000 NX | Sarstedt Aktiengesellschaft & Co.KG | 2 |
| Excyte 20 | ELITechGroup Inc | 2 |
Showing 12 of 47. All products under Device, Automated Sedimentation Rate
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-07-20 | Class II | Nonconforming Material/Component | Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube | 38 units |
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.