Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low - Pointe Methadone Metabolite (EDDP) Calibrator - POINTE SCIENTIFIC, INC.

Duns Number:045623154

Device Description: Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low 1 x 5 mL The Pointe Methadon Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low 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.

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More Product Details

Catalog Number

60-MM0384-5

Brand Name

Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low

Version/Model Number

60-MM0384-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K031797

Product Code Details

Product Code

DLJ

Product Code Name

Calibrators, Drug Specific

Device Record Status

Public Device Record Key

0f221d52-dd9c-4b3a-ab91-6a5d5bc2219f

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POINTE SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 455
U Unclassified 2