Mawi DNA Technologies
iSWAB-Discovery Human DNA Collection Tube 400 ul
4manufacturers in China registered for this device type
8catalogue 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 | Mawi DNA Technologies, 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 | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-06 |
| Record revised | 2024-06-19 (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, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Rack of 50, bag of 500 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ISD-T-1200 | In distribution | |
| ISF-T-DSC | In distribution | |
| iSWAB-DNA-1200 | In distribution | |
| ISWAB-DSC | In distribution | |
| ISF-T-250 | In distribution | |
| ISD-T-250 | In distribution | |
| ISWAB-DNA-250 | In distribution | |
| ISWAB-ID-250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| MagBio Genomics, Inc. | Magbio Genomics Inc. | 4 |
| 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.