| Primary Device ID | 00817405020218 |
| NIH Device Record Key | 2f0c1b32-5c46-4d48-86e2-78095216ee31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alere iScreen Dx |
| Version Model Number | IS1 OXY-DX |
| Catalog Number | IS1 OXY-DX |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 00817405020218 | Urine Drug Screen Card for detection of Oxycodone (OXY) single drug, CLIA Waived |
| 00817405020195 | Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Bupr |
| 00817405020188 | Urine Drug Screen Card for detection of 5 drugs, Amphetamine, Cocaine, Marijuana, Methamphetamin |
| 00817405020171 | Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca |
| 00817405020164 | Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca |
| 00817405020157 | Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Coca |
| 00817405020140 | Urine Drug Screen Card for detection of Buprenorphine (BUP) single drug, CLIA Waived |
| 00817405020133 | Urine Drug Screen Card for detection of Marijuana (THC) single drug, CLIA Waived |
| 00817405020126 | Urine Drug Screen Card for detection of Tricyclic Antidepressants (TCA) single drug, CLIA Waived |
| 00817405020119 | Urine Drug Screen Card for detection of Methadone (MTD) single drug, CLIA Waived |
| 00817405020102 | Urine Drug Screen Card for detection of Methamphetamine (MET) single drug, CLIA Waived |
| 00817405020096 | Urine Drug Screen Card for detection of Ecstasy (MDMA) single drug, CLIA Waived |
| 00817405020089 | Urine Drug Screen Card for detection of Morphine (MOP) single drug, CLIA Waived |
| 00817405020072 | Urine Drug Screen Card for detection of Cocaine (COC) single drug, CLIA Waived |
| 00817405020065 | Urine Drug Screen Card for detection of Benzodiazepine (BZO) single drug, CLIA Waived |
| 00817405020058 | Urine Drug Screen Card for detection of Barbiturate (BAR) single drug, CLIA Waived |
| 00817405020041 | Urine Drug Screen Card for detection of Amphetamine (AMP) single drug, CLIA Waived |
| 00817405020034 | Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived |