| Primary Device ID | 00894354002212 |
| NIH Device Record Key | 475c90fa-a30a-4a53-a91e-8d1e5400a15a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyCare Psychiatry |
| Version Model Number | MCP2-CAL |
| Catalog Number | MCP2-CAL |
| Company DUNS | 144379539 |
| Company Name | SALADAX BIOMEDICAL, 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 | false |
| 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 |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com | |
| Phone | +1 (610) 419-6731 |
| Techsupport@saladax.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894354002212 [Primary] |
| DLJ | Calibrators, Drug Specific |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-04 |
| Device Publish Date | 2022-01-27 |
| 00894354002311 | Control Kit 2 |
| 00894354002304 | Calibrator Kit 2 |
| 00894354002236 | Clozapine Assay Kit |
| 00894354002229 | Control Kit 2 |
| 00894354002212 | Calibrator Kit 2 |