| Primary Device ID | 00858945006942 |
| NIH Device Record Key | d73d28ad-0547-42d5-9b40-4b8fbc38d599 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urine Dip Card |
| Version Model Number | ATS-K2 |
| Catalog Number | ATS-K2 |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Phone | 1-800-340-4029 |
| lisa.bates@alere.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858945006942 [Primary] |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-09 |
| 00858945006959 | Single Drug Urine Test Panel, Fentanly, Employment And Insurance Testing, Exempt: FTY. |
| 00858945006942 | Single Drug Urine Test Panel, Synthetic Cannabinoids, Employment And Insurance Testing, Exempt: |
| 00858945006935 | Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA. |