Primary Device ID | 00894354002236 |
NIH Device Record Key | 67b6b8e4-4bcc-434a-a267-6d2dd6722a94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MyCare Psychiatry |
Version Model Number | CLZ-RGT |
Catalog Number | CLZ-RGT |
Company DUNS | 144379539 |
Company Name | SALADAX BIOMEDICAL, 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 | 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 |
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 | 00894354002236 [Primary] |
QKT | Clozapine Test System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-25 |
Device Publish Date | 2020-05-15 |
00894354002311 | Control Kit 2 |
00894354002304 | Calibrator Kit 2 |
00894354002236 | Clozapine Assay Kit |
00894354002229 | Control Kit 2 |
00894354002212 | Calibrator Kit 2 |