First Check
GUDID 00643281067555
FIRST CHECK DIAGNOSTIC CORP.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00643281067555 |
| NIH Device Record Key | bf3f6d9e-499e-4e11-9e1c-43801095b5b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Check |
| Version Model Number | 2 Drug Test |
| Company DUNS | 945331317 |
| Company Name | FIRST CHECK DIAGNOSTIC CORP. |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643281067555 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052115
FDA Product Code
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
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 | 2019-09-02 |
| Device Publish Date | 2016-06-30 |
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 |
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