Advin Multi-Drug Screen Test ABCard-02-02

GUDID B115ABCARD02021

OPI300/OXY100

ADVIN BIOTECH, INC.

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Primary Device IDB115ABCARD02021
NIH Device Record Keye63530ff-803a-4b34-96aa-b8cd3505f7fb
Commercial Distribution Discontinuation2030-07-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvin Multi-Drug Screen Test
Version Model Number1
Catalog NumberABCard-02-02
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB115ABCARD02020 [Unit of Use]
HIBCCB115ABCARD02021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

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 Date2016-08-23

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

B115ATCUP07091AMP500/BUP10/COC150/MET500/MOR300/OXY100/THC50
B115ATCUP06201AMP500/COC150/MET500/OPI2000/PCP25/THC50
B115ATCUP06011AMP500/BZO300/COC150/MET500/MOR300/THC50
B115ATCUP05101AMP500/COC150/MET500/OPI2000/THC50
B115ATCUP05021AMP500/COC150/MET500/MOR300/THC50
B115ATCARD06011AMP500/BZO300/COC150/MET500/MOR300/THC50
B115ATCARD05231AMP500/COC150/MET500/PCP25/THC50
B115ATCARD05101AMP500/COC150/MET500/OPI2000/THC50
B115ATCARD05021AMP500/COC150/MET500/MOR300/THC50
B115ABCUPH10131AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
B115ABCUPD12061AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50/(CR/OX/pH)
B115ABCUPD12021AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/OX/pH)
B115ABCUPC12021AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr
B115ABCUPC10131AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
B115ABCUPC06081AMP500/COC150/MDMA500/OPI2000/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
B115ABCUPC05361BZO300/COC150/MDMA500/OPI300/THC50/(Ox/SG/pH/Cr/Ni/Gl)
B115ABCUPB12021AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/GL/NI/CR
B115ABCUPB09071AMP500/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50/GL/NI/CR
B115ABCUPA14031AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/TCA1000/THC50
B115ABCUPA14021AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
B115ABCUPA13051AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/OXY/TCA/THC/(OX/pH/SG)
B115ABCUPA13011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
B115ABCUPA12211AMP500/BAR300/BUP10/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50/(OX/pH/SG)
B115ABCUPA12191AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50/(OX/pH/SG)
B115ABCUPA12131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50/(OX/pH/SG)
B115ABCUPA12101AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC/(OX/pH/SG)
B115ABCUPA12021AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC/(OX/pH/SG)
B115ABCUPA12011AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC/(OX/pH/SG)
B115ABCUPA11251AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/(OX/pH/SG)
B115ABCUPA11181AMP500/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(OX/pH/SG)
B115ABCUPA11131AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/(OX/pH/SG)
B115ABCUPA11071AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/PCP/PPX/THC/(OX/pH/SG)
B115ABCUPA11041AMP/BAR/BUP/BZO/COC/EDDP/MET/MTD/OPI/OXY/THC/(OX/pH/SG)
B115ABCUPA10341AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50/(OX/pH/SG)
B115ABCUPA10311AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
B115ABCUPA10301BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/THC50
B115ABCUPA10271AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
B115ABCUPA10191AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
B115ABCUPA10141BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
B115ABCUPA10131AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)
B115ABCUPA10121AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
B115ABCUPA10111AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/TCA1000/THC50/(OX/pH/SG)
B115ABCUPA10101(AMP500/OPI2000)/(COC/THC)/(MET/PCP)/BAR300/BZO300/MTD/PPX/(OX/pH/SG)
B115ABCUPA10091AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
B115ABCUPA10061AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC/(OX/pH/SG)
B115ABCUPA09071AMP500/BUP10/BZO300/COC150/MET500/MOR300/MTD300/OXY100/THC50/(OX/pH/SG)
B115ABCUPA09061AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
B115ABCUPA09031AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC/(OX/pH/SG)
B115ABCUPA08151AMP500/BUP10/BZO300/COC150/MET500/MOR300/OXY100/THC50/(OX/pH/SG)
B115ABCUPA08141AMP500/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
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