Methamphetamine Intercept 2 Plate Kit

GUDID 00608337000023

Orasure Technologies, Inc.

Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00608337000023
NIH Device Record Key88732dcc-733d-4559-bdf6-87be2c35dae8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMethamphetamine Intercept 2 Plate Kit
Version Model Number1104IT
Company DUNS114152184
Company NameOrasure Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com
Phone610-882-1820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

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