DrugSmart Cup C60963D
GUDID 00850019007497
DrugSmart Cup 9, THC/COC/MOR300/AMP/MET/BZO/MTD/BUP/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 00850019007497 |
| NIH Device Record Key | 6b585b22-cb7e-4064-8cbb-4730f5f23b95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DrugSmart Cup |
| Version Model Number | C60963D |
| Catalog Number | C60963D |
| Company DUNS | 795658603 |
| Company Name | CHEMTRON BIOTECH INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019007497 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142396
FDA Product Code
| DJR | Enzyme Immunoassay, Methadone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-27 |
On-Brand Devices [DrugSmart Cup]
| 00850019007640 | DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2000/PCP/TCA/THC, 25 tests/kit |
| 00850019007589 | DrugSmart Cup 9, AMP/BAR/BZO/COC/MTD/OPI2K/PCP/PPX/THC, 25tests/kit |
| 00850019007503 | DrugSmart Cup 12, THC/COC/MOR300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY, 25pcs/kit |
| 00850019007497 | DrugSmart Cup 9, THC/COC/MOR300/AMP/MET/BZO/MTD/BUP/OXY, 25pcs/kit |
| 00850019007480 | DrugSmart Cup 6, AMP/COC/THC/OPI2000/MET/OXY, 25pcs/kit |
| 00850019007138 | DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI2000/TCA/THC, 25pcs/kit |
| 00850019007121 | DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit |
| 00850019007114 | DrugSmart Cup 5, AMP/COC/MET/OPI/THC, 25pcs/kit |
| 00812203030698 | DrugSmart Cup 4, AMP/COC/MET/OPI2K, 25 tests/kit |
Trademark Results [DrugSmart Cup]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRUGSMART CUP 77625474 3646777 Live/Registered |
TWIN SPIRIT, INC. 2008-12-03 |
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