Amphetamines Panel Level 1 41400

GUDID B800414005

Amphetamines Panel Level 1

UTAK LABORATORIES, INC.

Amphetamine/methamphetamine group IVD, control
Primary Device IDB800414005
NIH Device Record Key85c48c40-c530-42ae-9413-298c466f07ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmphetamines Panel Level 1
Version Model Number41400
Catalog Number41400
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
HIBCCB800414000 [Primary]
HIBCCB800414005 [Package]
Contains: B800414000
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 1]

B800414005Amphetamines Panel Level 1
B800AMPH1UFUW5AMPHETAMINES PANEL LEVEL 1

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