FDA.reportPublic FDA data

QMS Topiramate Immunoassay

Primary DI
00884883011298
Brand
QMS Topiramate Immunoassay
Company
Microgenics Corporation
Model
0374173
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
00884883011298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883011298008848830112988848830112980884883011298

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.

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
00884883011175QMS Topiramate ImmunoassayMicrogenics CorporationNWM2016-09-24
00884883011199QMS Zonisamide ImmunoassayMicrogenics CorporationNWM2016-09-24
00884883012707QMS Topiramate AssayMicrogenics CorporationNWM2016-09-12
00884883012714QMS Zonisamide AssayMicrogenics CorporationNWM2016-09-12