Multi-Analyte DAU Calibrator Set E, Low Calibrator - 15 mL/bottle.Concentration of Multi-Analyte: 100 - LIN-ZHI INTERNATIONAL, INC.

Duns Number:840839190

Device Description: 15 mL/bottle.Concentration of Multi-Analyte: 100 ng/mL secobarbital, 5 ng/mL norbuprenorph 15 mL/bottle.Concentration of Multi-Analyte: 100 ng/mL secobarbital, 5 ng/mL norbuprenorphine, 150 ng/mL methadone, and 12.5 ng/mL phencyclidine.

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More Product Details

Catalog Number

0892

Brand Name

Multi-Analyte DAU Calibrator Set E, Low Calibrator

Version/Model Number

0892

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

DKB

Product Code Name

Calibrators, Drug Mixture

Device Record Status

Public Device Record Key

5b034532-9340-48aa-85fc-a633bb8f6b9e

Public Version Date

April 03, 2019

Public Version Number

1

DI Record Publish Date

March 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIN-ZHI INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 258
U Unclassified 2