DrugSmart Dip 30510D
GUDID 00859144006283
AMP/BAR/BZO/COC/THC DipCard
Twin Spirit Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00859144006283 |
| NIH Device Record Key | beef849e-8a01-429f-93ef-51336035ce0e |
| Commercial Distribution Discontinuation | 2018-06-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DrugSmart Dip |
| Version Model Number | 30510D |
| Catalog Number | 30510D |
| Company DUNS | 617011296 |
| Company Name | Twin Spirit 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | false |
Customer Support Contacts
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com | |
| Phone | 1-760-494-7502 |
| info@nativediagnostics.com |
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 | 00859144006283 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113046
FDA Product Code
| LDJ | Enzyme Immunoassay, Cannabinoids |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-28 |
| Device Publish Date | 2016-09-01 |
On-Brand Devices [DrugSmart Dip]
| 00859144006320 | COC/MET1000/THC DipCard |
| 00859144006313 | (BZO/BAR)+AMP+COC+OPI2000+THC DipCard |
| 00859144006306 | AMP/BAR/COC/OPI2000/THC Dipcard |
| 00859144006290 | AMP/BZO/COC/OPI2000/THC Dipcard |
| 00859144006283 | AMP/BAR/BZO/COC/THC DipCard |
| 00859144006276 | AMP/COC/MET1000/OPI2000/THC DipCard |
| 00859144006269 | (BZO/BAR)+(MET1000/OPI2000)+AMP+COC+THC DipCard |
| 00859144006252 | COC/MET1000/OPI300/THC DipCard |
| 00859144006245 | (MET1000/OPI2000)+AMP+BZO+COC+THC DipCard |
Trademark Results [DrugSmart Dip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRUGSMART DIP 77381997 3492348 Live/Registered |
TWIN SPIRIT, INC. 2008-01-28 |
 DRUGSMART DIP 77014153 not registered Dead/Abandoned |
Twin Spirit, Inc. 2006-10-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.