Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate 60-MM0388-5

GUDID 00811727018175

Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 300 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 300 ng/mL on automated clinical chemistry analyzers.

POINTE SCIENTIFIC, INC.

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Primary Device ID00811727018175
NIH Device Record Key05908fa1-33e6-411d-aa54-f2356e4e0b72
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate
Version Model Number60-MM0388-5
Catalog Number60-MM0388-5
Company DUNS045623154
Company NamePOINTE SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727018175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

Devices Manufactured by POINTE SCIENTIFIC, INC.

00811727015709 - Pointe Alkaline Phosphatase on the BS4802023-07-06 Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline
00811727015723 - Pointe Amylase on BS480 Analyzer2023-07-06 Pointe Amylase packaged for use on the BS480 Analyzer. 6x20mL kit. For the quantitative kinetic determination of a-amylase activ
00811727015730 - Pointe AST on the BS480 Analyzer2023-07-06 Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotran
00811727015754 - Pointe Calcium Arsenazo for BS4802023-07-06 Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or h
00811727015778 - Pointe Cholesterol on BS4802023-07-06 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in
00811727015792 - Pointe Carbon Dioxide on the BS4802023-07-06 Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For the quantitative determination of Carbon Dioxide
00811727015839 - Pointe GGT on BS4802023-07-06 Pointe GGT Reagent packaged for use on the BS480. 4x40mL 4x10mL Kit. For the quantitative kinetic determination of gamma glutamy
00811727015846 - Pointe Glucose Hexokinase for BS4802023-07-06 Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of gluco
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.