MyCare Psychiatry MCP2-CON-US

GUDID 00894354002311

Control Kit 2

SALADAX BIOMEDICAL, INC.

Clozapine IVD, control
Primary Device ID00894354002311
NIH Device Record Key7a028ac6-6af6-4d1d-b055-e87f4b39c447
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyCare Psychiatry
Version Model NumberMCP2-CON-US
Catalog NumberMCP2-CON-US
Company DUNS144379539
Company NameSALADAX BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com
Phone+1 (610) 419-6731
EmailTechsupport@saladax.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100894354002311 [Primary]

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-15

On-Brand Devices [MyCare Psychiatry]

00894354002311Control Kit 2
00894354002304Calibrator Kit 2
00894354002236Clozapine Assay Kit
00894354002229Control Kit 2
00894354002212Calibrator Kit 2

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