First Check
GUDID 00643281801128
FIRST CHECK DIAGNOSTIC CORP.
Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00643281801128 |
| NIH Device Record Key | 5fe118b0-b46f-4b63-a751-b1924eccdd3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Check |
| Version Model Number | THC Test- 2 pack |
| Company DUNS | 945331317 |
| Company Name | FIRST CHECK DIAGNOSTIC CORP. |
| Device Count | 2 |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643281801128 [Primary] |
| GS1 | 00643281990402 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052115
FDA Product Code
| NFW | Test, Cannabinoid, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-16 |
| Device Publish Date | 2019-09-06 |
On-Brand Devices [First Check]
| 00643881069078 | 7 Drug Test |
| 00643281069047 | 4 Drug Test |
| 00643281067555 | 2 Drug Test |
| 00643281061553 | First Check Home Drug Test One Drug Marijuana |
| 00643281801128 | THC Test- 2 pack |
| 00643281069078 | 7 Drug Test |
Trademark Results [First Check]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIRST CHECK 79053913 not registered Dead/Abandoned |
Inverness Medical Switzerland GmbH 2008-02-29 |
 FIRST CHECK 78920560 3689453 Dead/Cancelled |
First Horizon National Corporation 2006-06-30 |
 FIRST CHECK 77543468 3775613 Live/Registered |
FIRST CHECK DIAGNOSTICS, LLC 2008-08-11 |
 FIRST CHECK 77085666 3338418 Live/Registered |
FIRST CHECK DIAGNOSTICS, LLC 2007-01-18 |
 FIRST CHECK 75047865 2023956 Live/Registered |
FIRST CHECK DIAGNOSTICS, LLC 1996-01-24 |
 FIRST CHECK 74562878 1955818 Dead/Cancelled |
WORLDWIDE MEDICAL CORPORATION 1994-08-19 |
 FIRST CHECK 73293917 not registered Dead/Abandoned |
FIRST FEDERAL SAVINGS & LOAN ASSOCIATION 1981-01-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.