eCUP + Drug Screening Device 94615

GUDID 00816565021530

13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni

AMEDITECH INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816565021530
NIH Device Record Key3edc8f16-e1fc-4cee-9357-168dae8c65ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameeCUP + Drug Screening Device
Version Model Number94615
Catalog Number94615
Company DUNS010551716
Company NameAMEDITECH INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-619-318-4969
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816565021530 [Primary]

FDA Product Code

PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

Devices Manufactured by AMEDITECH INC.

00816565021530 - eCUP + Drug Screening Device2020-03-2513 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni
00816565021530 - eCUP + Drug Screening Device2020-03-25 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni
00816565021547 - eREADER+ Drug Screening Instrument2020-03-13 ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni.
00816565021240 - Fastect II Drug Screen Dipstick Test2019-01-30 THC50/COC300/OPI300 multiple drugs dipstick test
00816565020564 - AmediCheck Instant Test Cup2019-01-30 THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup
00816565020342 - ImmuTest Drugs of Abuse Cup2019-01-30 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests (for Impact Employees)
00816565020335 - ImmuTest Drugs of Abuse Cup2019-01-30 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
00816565020281 - ImmuTest Drugs of Abuse Cup2019-01-30 8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
00816565020274 - ImmuTest Drugs of Abuse Cup2019-01-30 6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests

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