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QMS Topiramate Immunoassay

Primary DI
00884883011175
Brand
QMS Topiramate Immunoassay
Company
Microgenics Corporation
Model
0374140
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NWMImmunoassay, Anti-Seizure Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWMImmunoassay, Anti-Seizure DrugClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070645000SERADYN QMS TOPIRAMATESeradyn, Inc.2007-05-17NWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883011175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883011175008848830111758848830111750884883011175

GMDN Terms#

Term, Definition table
TermDefinition
Topiramate therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of therapeutic monitoring of the central nervous system drug topiramate in a clinical specimen using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884883009080MAS Immunology Advanced Sample PackICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1ICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2ICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3ICA-3032026-05-27
00884883011427CRP (C-Reactive Protein)75-54422026-05-27
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812101031261ARK™ Pregabalin II Assay ARK DIAGNOSTICS INCNWM2023-12-22
00812101030448ARK™ Pregabalin II AssayARK DIAGNOSTICS INCNWM2019-07-03
00884883011250QMS Topiramate Immunoassay Control setMicrogenics CorporationNWM2016-10-04
00858724003001ARK™ Topiramate AssayARK DIAGNOSTICS INCNWM2016-09-24
00858724003018ARK™ Zonisamide AssayARK DIAGNOSTICS INCNWM2016-09-24
00858724003278ARK™ Pregabalin Urine AssayARK DIAGNOSTICS INCNWM2016-09-24
00884883011199QMS Zonisamide ImmunoassayMicrogenics CorporationNWM2016-09-24
00884883011298QMS Topiramate Immunoassay Microgenics CorporationNWM2016-09-24
00884883012707QMS Topiramate AssayMicrogenics CorporationNWM2016-09-12
00884883012714QMS Zonisamide AssayMicrogenics CorporationNWM2016-09-12