Pointe Cannabinoid (THC) Reagent Set 60-CA0140-1L

GUDID 00811727017253

Pointe Cannabinoid (THC) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.

POINTE SCIENTIFIC, INC.

Cannabinoid IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00811727017253
NIH Device Record Key268c15ed-ca47-46a3-a878-afbfb89a5c53
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Cannabinoid (THC) Reagent Set
Version Model Number60-CA0140-1L
Catalog Number60-CA0140-1L
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
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
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
GS100811727017253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

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

On-Brand Devices [Pointe Cannabinoid (THC) Reagent Set]

00811727017253Pointe Cannabinoid (THC) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Cannabinoids (THC)
00811727017246Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC)

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