Immunalysis

Primary DI
00840937110263
Brand
Immunalysis
Company
IMMUNALYSIS CORP
Model
331UR-0025
Catalog number
331UR-0025
Device description
Carisoprodol Metabolite/Meprobamate Urine HEIA™
Published
2017-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QBKMeprobamate test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBKMeprobamate Test SystemClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190397000Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAImmunalysis Corporation2019-11-15QBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937110263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937110263008409371102638409371102630840937110263

GMDN Terms#

Term, Definition table
TermDefinition
Carisoprodol IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carisoprodol in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002804244
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
00840937114636Immunalysis10063-1510063-152024-04-19
00840937114643Immunalysis10064-1510064-152024-04-19
00840937114650Immunalysis10065-1510065-152024-04-19
00840937114667Immunalysis10066-1510066-152024-04-19
00840937114674Immunalysis3020-153020-152024-04-19
00840937114568Immunalysis10068-1510068-152024-04-08
00840937114605ImmunalysisNegOFLP-0100NegOFLP-01002024-04-08
00840937103265Immunalysis10047-1010047-102023-10-26
00840937103272Immunalysis10048-1010048-102023-10-26
00840937103289Immunalysis10049-1010049-102023-10-26
00840937103296Immunalysis10050-1010050-102023-10-26
00840937112076Immunalysis3017-103017-102021-02-05
00840937112083Immunalysis10054-1010054-102021-02-05
00840937112090Immunalysis10053-1010053-102021-02-05
00840937112106Immunalysis10052-1010052-102021-02-05
00840937112113Immunalysis10051-1010051-102021-02-05
00840937111895Immunalysis10055-1010055-102020-03-31
00840937111918Immunalysis10056-1010056-102020-03-31
00840937111925Immunalysis10057-1010057-102020-03-31
00840937111932Immunalysis10058-1010058-102020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018380Pointe Carisporodol Metabolite (SOMA) Reagent SetHORIBA INSTRUMENTS INCORPORATEDQBK2020-09-25
00811727018397Pointe Carisporodol Metabolite (SOMA) Reagent SetHORIBA INSTRUMENTS INCORPORATEDQBK2020-09-25
B07603700Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603710Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603720Carisprodol Metabolite (Meprobamate) DAU Calibrator, Low CalibratorLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603730Carisprodol Metabolite (Meprobamate) DAU Calibrator, Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603740Carisprodol Metabolite (Meprobamate) DAU Calibrator, Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603750Carisprodol Metabolite (Meprobamate) DAU Calibrator, High CalibratorLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603770Carisprodol Metabolite (Meprobamate) DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
B07603780Carisprodol Metabolite (Meprobamate) DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.QBK2018-09-18
00840937110270ImmunalysisIMMUNALYSIS CORPQBK2017-09-07
00840937110287ImmunalysisIMMUNALYSIS CORPQBK2017-09-07
00840937110294ImmunalysisIMMUNALYSIS CORPQBK2017-09-07