FDA.reportPublic FDA data

Beckman Coulter

Primary DI
00894354002397
Brand
Beckman Coulter
Company
SALADAX BIOMEDICAL, INC.
Model
C82914
Catalog number
C82914
Device description
Psychiatry Clozapine Assay Kit
Published
2022-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKTClozapine Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKTClozapine Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190028000MyCare Psychiatry Clozapine Assay KitSaladax Biomedical, Inc.2020-04-16QKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894354002397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894354002397008943540023978943540023970894354002397

GMDN Terms#

Term, Definition table
TermDefinition
Clozapine IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of clozapine in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (610) 419-6731Techsupport@saladax.com

Regulatory Flags#

DUNS number
144379539
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894354002366Beckman CoulterC82911C829112022-06-15
00894354002373Beckman CoulterC82912C829122022-06-15
00894354002304MyCare PsychiatryMCP2-CAL-USMCP2-CAL-US2020-05-15
00894354002311MyCare PsychiatryMCP2-CON-USMCP2-CON-US2020-05-15
00894354002212MyCare PsychiatryMCP2-CALMCP2-CAL2022-01-27
00894354002229MyCare PsychiatryMCP2-CONMCP2-CON2022-01-27
00894354002236MyCare PsychiatryCLZ-RGTCLZ-RGT2020-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894354002236MyCare PsychiatrySALADAX BIOMEDICAL, INC.QKT2020-05-15