Cue Sample Collection Kit
Sample Collection Kit, Urine Collection Device and Kit Accessories
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Equinox Biotech Co., Ltd. | Shantou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Cue Health, Inc., United States |
|---|---|
| FDA product code | OIE |
| Device type | Urine Collection Kit (Excludes Hiv Testing) |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Premarket notification | Exempt |
| Record published | 2023-02-27 |
| Record revised | 2023-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C2240 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 15 |
| Medline | Medline Industries, Inc. | 4 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Recopad | Medfire Innovations Inc. | 3 |
| Smilereader ovulation test kit | Equinox Biotech Co., Ltd. | 3 |
| David | Equinox Biotech Co., Ltd. | 3 |
| Everlywell Urine Collection Kit | Everly Health, Inc. | 2 |
| Urine Raku-Ryu Cup | Takahashi Keisei Corporation | 2 |
| Therapak | Therapak, LLC | 2 |
| BD Vacutainer Urine Complete Cup Kit | Becton, Dickinson AND Company | 2 |
| SureStep Vacutainer Urine Sampling Kit | C.R. Bard, Inc. | 2 |
| LotFancy | Equinox Biotech Co., Ltd. | 1 |
Showing 12 of 32. All products under Urine Collection Kit (Excludes Hiv Testing)
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.