ALPRAZOLAM PLUS CALIBRATOR LEVEL 1 - UTAK LABORATORIES, INC.

Duns Number:092519016

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More Product Details

Catalog Number

-

Brand Name

ALPRAZOLAM PLUS CALIBRATOR LEVEL 1

Version/Model Number

ALP+ CAL 1 V3 U F PT

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)

-

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

LAS

Product Code Name

Drug Specific Control Materials

Device Record Status

Public Device Record Key

32fe9c8a-5288-4ec8-8261-adc70b2e819b

Public Version Date

May 12, 2022

Public Version Number

1

DI Record Publish Date

May 04, 2022

Additional Identifiers

Package DI Number

B80003750000011

Quantity per Package

4

Contains DI Package

B80003750000010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113