Amphetamines Panel Level 2 41401

GUDID B800414015

Amphetamines Panel Level 2

UTAK LABORATORIES, INC.

Amphetamine/methamphetamine group IVD, control
Primary Device IDB800414015
NIH Device Record Key493bdad7-e34d-43e8-a93f-0da5bd0570ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmphetamines Panel Level 2
Version Model Number41401
Catalog Number41401
Company DUNS092519016
Company NameUTAK LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-882-5522
Emailwelovecontrol@utak.com

Device Dimensions

Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800414010 [Primary]
HIBCCB800414015 [Package]
Contains: B800414010
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

On-Brand Devices [Amphetamines Panel Level 2 ]

B800414015Amphetamines Panel Level 2
B800AMPH2UFUW5AMPHETAMINES PANEL LEVEL 2

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