Advin Multi-Drug Screen Test with SVT ABCupC-07-43

GUDID B115ABCUPC07430

BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)

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
Primary Device IDB115ABCUPC07430
NIH Device Record Keyd9ff27e9-b525-4ce4-9664-57a4eaab70a0
Commercial Distribution Discontinuation2080-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvin Multi-Drug Screen Test with SVT
Version Model NumberABCupC-07-43
Catalog NumberABCupC-07-43
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07430 [Unit of Use]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]
HIBCCB115ABCUPC07431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine
JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

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

B115ABCUPD10161AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/Ph)
B115ABCUPD05021AMP500/COC150/MET500/OPI300/THC50/(CR/OX/Ph)
B115ABCUPA05091AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
B115ABCARDD10161AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/pH)
B115ABCARDD05021AMP500/COC150/MET500/OPI300/THC50/(CR/OX/pH)
B115ABCUPE05021AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
B115ABCARDE05021AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
B115ABCUPD12011AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(CR/OX/pH)
B115ABCARDD12011AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
B115ABCUPA11390AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
B115ABCARDA11390AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
B115ABCUPC12710AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/N
B115ABCUPC12440AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/N
B115ABCARDC12710AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/N
B115ABCARDC12440AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/N
B115ABCUPC07430BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
B115ABCARDC07430BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)

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