Beckman Coulter C82914

GUDID 00894354002397

Psychiatry Clozapine Assay Kit

SALADAX BIOMEDICAL, INC.

Clozapine IVD, reagent
Primary Device ID00894354002397
NIH Device Record Key486a31b1-0dbc-4375-8233-2c16e37897c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeckman Coulter
Version Model NumberC82914
Catalog NumberC82914
Company DUNS144379539
Company NameSALADAX BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100894354002397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKTClozapine Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-23
Device Publish Date2022-06-15

On-Brand Devices [Beckman Coulter]

00894354002397Psychiatry Clozapine Assay Kit
00894354002373Psychiatry Control Kit 2
00894354002366Psychiatry Calibrator Kit 2

Trademark Results [Beckman Coulter]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BECKMAN COULTER
BECKMAN COULTER
98161690 not registered Live/Pending
Beckman Coulter, Inc.
2023-09-01
BECKMAN COULTER
BECKMAN COULTER
78278612 2884295 Live/Registered
BECKMAN COULTER, INC.
2003-07-24
BECKMAN COULTER
BECKMAN COULTER
77645090 3842369 Live/Registered
Beckman Coulter, Inc.
2009-01-07
BECKMAN COULTER
BECKMAN COULTER
75836378 2742502 Live/Registered
Beckman Coulter, Inc.
1999-10-29
BECKMAN COULTER
BECKMAN COULTER
75836377 2756542 Live/Registered
Beckman Coulter, Inc.
1999-10-29
BECKMAN COULTER
BECKMAN COULTER
75834324 2970877 Live/Registered
Beckman Coulter, Inc.
1999-10-29

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