MyCare Psychiatry MCP2-CAL-US

GUDID 00894354002304

Clozapine IVD, calibrator

Primary Device ID	00894354002304
NIH Device Record Key	669c21a8-1bcd-4484-8c54-4acb9c70e7b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	MyCare Psychiatry
Version Model Number	MCP2-CAL-US
Catalog Number	MCP2-CAL-US
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

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	00894354002304 [Primary]

DLJ	Calibrators, Drug Specific

Steralize Prior To Use	false
Device Is Sterile	false