FDA.reportPublic FDA data

Pointe Propoxyphene (PPX) Reagent Set

Primary DI
00811727017925
Brand
Pointe Propoxyphene (PPX) Reagent Set
Company
HORIBA INSTRUMENTS INCORPORATED
Model
60-PP0240-1L
Catalog number
60-PP0240-1L
Device description
Pointe Propoxyphene (PPX) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Propoxyphene (PPX) Reagent Set is intended for the qualitative and semi-quantitative determination of propoxyphene in human urine at a cutoff value of 300 ng/mL. 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
JXNEnzyme Immunoassay, Propoxyphene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023795000PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.2003-01-21JXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727017925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727017925008117270179258117270179250811727017925

GMDN Terms#

Term, Definition table
TermDefinition
Propoxyphene 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 propoxyphene 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810173656788HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXN2026-06-02
07290006418326CHROMOSTREAKSAVYON DIAGNOSTICS LTDJXN2026-05-27
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONJXN2021-06-24
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10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-03-21
10694644500216RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-03-13
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