Immutest Drugs of Abuse Screen Device IMD-9AMJ

GUDID 00816565021325

ImmuTest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA

AMEDITECH INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816565021325
NIH Device Record Keyc5a3bdd2-a9d3-4d45-956b-c6d2fc344e21
Commercial Distribution Discontinuation2018-09-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameImmutest Drugs of Abuse Screen Device
Version Model NumberIMD-9AMJ
Catalog NumberIMD-9AMJ
Company DUNS010551716
Company NameAMEDITECH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816565021325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-21
Device Publish Date2017-05-01

On-Brand Devices [Immutest Drugs of Abuse Screen Device]

00816565021516(COC/THC)+(MET/OPI)+(PCP/AMP)+BAR+BZO+MTD+OXY with Cr, Ni, pH, Bl, S.G. adulteration tests
00816565021325ImmuTest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA
00816565021318Immutest (COC/THC)+(PCP/AMP)+BAR+BZO+MET+OPI+TCA with Cr, Ni, pH, Bl, S.G. adulteration tests
00816565021301AMP+MET+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
00816565021295Immutest AMP+MET+THC
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