Advin Multi-Drug Screen Test ABCard-11-37

GUDID B115ABCARD11370

AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25

ADVIN BIOTECH, 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, 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
Primary Device IDB115ABCARD11370
NIH Device Record Keye7289b26-a400-4c3c-b47a-a666649d13c3
Commercial Distribution Discontinuation2080-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvin Multi-Drug Screen Test
Version Model Number1
Catalog NumberABCard-11-37
Company DUNS006463333
Company NameADVIN BIOTECH, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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-Countertrue

Customer Support Contacts

Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com
Phone(855)866-8382
Emailinfo@advinbio.com

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB115ABCARD11370 [Unit of Use]
HIBCCB115ABCARD11371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-17

On-Brand Devices [Advin Multi-Drug Screen Test ]

B115ABCUPC14011AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
B115ABCUPA14011AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCUPA12091AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50/(OX/pH/SG)
B115ABCUPA12061AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCUPA11011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/OXY/PCP/THC/(OX/pH/SG)
B115ABCUPA10231AMP500/BAR300/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/(OX/pH/SG)
B115ABCUPA10201AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
B115ABCUPA10161AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY/PCP/THC/(OX/pH/SG)
B115ABCUP14031AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/TCA1000/THC50
B115ABCUP14021AMP/ BAR/BUP /BZO /COC /MDMA /MET /MTD /PCP/PPX /OXY /TCA /THC /OPI2000
B115ABCUP14011AMP /BAR /BUP /BZO /COC /EDDP /MDMA /MET /MOR /MTD /OXY /PCP /TCA /THC
B115ABCUP13051AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/ OXY/TCA/THC
B115ABCUP13011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
B115ABCUP12131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50
B115ABCUP12101AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
B115ABCUP12091AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
B115ABCUP12061AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
B115ABCUP12021AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC
B115ABCUP12011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC
B115ABCUP11131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000
B115ABCUP11071AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/PCP/PPX/THC
B115ABCUP11041AMP/BAR/BUP/BZO/COC/EDDP/MET/MTD/OPI/OXY/THC
B115ABCUP11011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/OXY/PCP/THC
B115ABCUP10271AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/THC50
B115ABCUP10231AMP500/BAR300/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY
B115ABCUP10201AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
B115ABCUP10191AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
B115ABCUP10161AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY /PCP/THC
B115ABCUP10141BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50
B115ABCARDC14011AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
B115ABCARDA14011AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCARDA13011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCARDA12061AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCARDA11131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/(OX/pH/SG)
B115ABCARDA10191AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
B115ABCARD14031AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/TCA1000/THC50
B115ABCARD14021AMP/BAR/BUP/BZO/COC/MDMA/MAMP/MTD/PCP/PPX/OXY/TCA/THC/OPI2000
B115ABCARD14011AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
B115ABCARD13051AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/ OXY/TCA/THC
B115ABCARD13011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
B115ABCARD12131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50
B115ABCARD12101AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
B115ABCARD12091AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
B115ABCARD12061AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC
B115ABCARD12021AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC
B115ABCARD12011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC
B115ABCARD11131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000
B115ABCARD11071AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/PCP/PPX/THC
B115ABCARD11041AMP/BAR/BUP/BZO/COC/EDDP/MET/MTD/OPI/OXY/THC
B115ABCARD11011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/OXY/PCP/THC

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