MagBio Genomics, Inc.
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| International Haotian Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
Record
| Listed by | Magbio Genomics Inc., United States |
|---|---|
| FDA product code | NNL |
| Device type | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MagBio CTL Medium MAX (500 mL) | In distribution | |
| MagBio CTL Medium VIRAL (500 mL) | In distribution | |
| MagBio CTL Medium VIRAL (1000 mL) | In distribution | |
| MagBio CTL Medium MAX (1000 mL) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mawi DNA Technologies | Mawi DNA Technologies | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| ACS Combo-B Incubator | BSL Co., Ltd. | 2 |
| Cool transport container | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| Aero-Med | Aero-MED LLC | 1 |
| ClinicoLab | Surgyco LLC | 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.