FDA.reportPublic FDA data

Pointe Carisporodol Metabolite (SOMA) Reagent Set

Primary DI
00811727018380
Brand
Pointe Carisporodol Metabolite (SOMA) Reagent Set
Company
HORIBA INSTRUMENTS INCORPORATED
Model
60-CM0740-100
Catalog number
60-CM0740-100
Device description
Pointe Carisporodol Metabolite (SOMA) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Carisoprodol Metabolite (SOMA) Reagent Set is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
DEN170010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170010000LZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayLin-Zhi International, Inc.2018-04-20QBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727018380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727018380008117270183808117270183800811727018380

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

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtestdx.com

Regulatory Flags#

DUNS number
052845583
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
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840937110263ImmunalysisIMMUNALYSIS CORPQBK2017-09-07
00840937110270ImmunalysisIMMUNALYSIS CORPQBK2017-09-07
00840937110287ImmunalysisIMMUNALYSIS CORPQBK2017-09-07
00840937110294ImmunalysisIMMUNALYSIS CORPQBK2017-09-07