FDA.reportPublic FDA data

Pointe Multi-Analyte Set D Urine DAU Negative Calibrator

Primary DI
00811727017611
Brand
Pointe Multi-Analyte Set D Urine DAU Negative Calibrator
Company
POINTE SCIENTIFIC, INC.
Model
60-MA1742-15
Catalog number
60-MA1742-15
Device description
Pointe Multi-Analyte Set D Urine DAU Negative Calibrator 1 x 15 mL The Pointe Multi-Analyte Set D Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs ofabuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, morphine, oxazepam, and oxycodone in human urine on a number of automated clinical chemistry analyzers.
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKBCalibrators, Drug Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727017611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727017611008117270176118117270176110811727017611

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

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
045623154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
00811727018632Pointe Scientific CK-MBC7563-30C7563-302021-02-28
00811727018649Pointe Scientific CK-MBC7563-90C7563-902021-02-28
00811727014139Pointe G6PD ReagentG7583-180G7583-1802021-01-30
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00811727015679Pointe G6PD ControlsG7583-CTLG7583-CTL2021-01-30
00811727015815Pointe CRP Reagent14-C7568-48014-C7568-4802021-01-30
00811727015891Pointe Lactate Reagent 14-L7596-38014-L7596-3802021-01-30
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20613647025295FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
00840937112083Immunalysis CorporationIMMUNALYSIS CORPORATIONDKB2021-02-05
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00840937112106Immunalysis CorporationIMMUNALYSIS CORPORATIONDKB2021-02-05
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00811727016850Pointe Universal Negative CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017550Pointe Multi-Analyte Set C Urine DAU Low CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017567Pointe Multi-Analyte Set C Urine DAU Cutoff CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017628Pointe Multi-Analyte Set D Urine DAU Low CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017642Pointe Multi-Analyte Set D Urine DAU Intermediate CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
00811727017727Pointe Multi-Analyte E DAU High CalibratorPOINTE SCIENTIFIC, INC.DKB2020-09-25
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00380740179359AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179366AlinityABBOTT LABORATORIESDKB2020-05-11
00840937111895Immunalysis CorporationIMMUNALYSIS CORPORATIONDKB2020-03-31
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00840937111925Immunalysis CorporationIMMUNALYSIS CORPORATIONDKB2020-03-31
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