US Agent Collection Oral Fluid Kit
Catalogue number Exempt, listed by Quest Diagnostics, Inc., United States, under Container, Specimen Mailer And Storage, Sterile. 33 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Guangdong (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
Showing 12 of 33. All 33 manufacturers in China registered for Container, Specimen Mailer And Storage, Sterile
Record
| Listed by | Quest Diagnostics, Inc., United States |
|---|---|
| FDA product code | KDT |
| Device type | Container, Specimen Mailer And Storage, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Premarket notification | Exempt |
| Record published | 2024-01-15 |
| Record revised | 2024-04-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Packaging | Pack of 5, pack of 10, pack of 25, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Exempt | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cryo.s | Greiner BIO-ONE Gmbh | 165 |
| Globe Scientific | Globe Scientific, LLC | 35 |
| Micro tube 2ml, PP | Sarstedt Aktiengesellschaft & Co.KG | 29 |
| Caplugs/Evergreen | Caplugs, Inc. | 21 |
| Micro tube 1.5ml, PP | Sarstedt Aktiengesellschaft & Co.KG | 19 |
| Micro tube 0.5ml, PP | Sarstedt Aktiengesellschaft & Co.KG | 18 |
| Wellbrace | Pantymed S.A. | 11 |
| Renonmed | Zhejiang Renon Medical Instrument Co., Ltd. | 8 |
| micro tube 1,5 ml | Sarstedt Aktiengesellschaft & Co.KG | 6 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 5 |
| micro tube 2 ml | Sarstedt Aktiengesellschaft & Co.KG | 5 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
Showing 12 of 196. All products under Container, Specimen Mailer And Storage, Sterile
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.