Accurun®
ACCURUN 140 Rubella IgG 1 x 5.0 mL
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
Record
| Listed by | LGC Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | MJX |
| Device type | Kit, Serological, Positive Control |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K972986 |
| Record published | 2018-09-24 |
| Record revised | 2023-08-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2015-0084 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 1 |
| RSV Positive Control | Meridian Bioscience, Inc. | 1 |
| Serology Lyme Disease Positive Control (Lyme Control +) | Randox Laboratories Limited | 1 |
| Alinity | Abbott Medical | 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.