Rtcii 1st Gen.
RTC II 6MZX2-515 LOW Cutoff A
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
Record
| Listed by | American Bio Medica Corp., United States |
|---|---|
| FDA product code | DKE |
| Device type | Reagents, Test, Tetrahydrocannabinol |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3870 |
| 510(k) | K073078 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 59 to 86 °F; Handling environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-11SPX2B-400 | 200 | In distribution | |
| 10-11SPX2A-515 | 25 | In distribution |
Same Product Code
Showing 12 of 38. All products under Reagents, Test, Tetrahydrocannabinol
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.