ToxCup Drug Screen Cup HT15A

GUDID 00816555020369

AMP1000/COC300/MET500/PCP25/THC50/OPI2000 Adulteration Screen for CR/NI/PH/BL/SG

BRANAN MEDICAL CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816555020369
NIH Device Record Keyf4c016c7-b73a-4cae-bbfa-76a68957e4fc
Commercial Distribution Discontinuation2018-10-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameToxCup Drug Screen Cup
Version Model NumberHT15A
Catalog NumberHT15A
Company DUNS184347305
Company NameBRANAN MEDICAL CORPORATION
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

Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816555020369 [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 Number4
Public Version Date2018-10-02
Device Publish Date2016-08-01

On-Brand Devices [ToxCup Drug Screen Cup]

00816555021526THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25
00816555021519AMP1000/COC300/MET500/OPI2000/THC50
00816555020673THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 with C
00816555020666COC300/MET500/OPI2000/THC50/OXY100
00816555020659AMP1000/COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020642AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020635AMP1000/COC300/OPI300/PCP25/BAR300 Adulteration Screen for CR-NI-PH-OX
00816555020628COC300/MET500/OPI300/THC50/OXY100
00816555020611COC300/MET500/OPI300/THC50/BZO300 Adulteration Screen for CR/NI/PH/BL/SG
00816555020604COC300/MET500/OPI300/THC50/BZO300
00816555020598AMP1000/COC300/OPI300/THC50/BZO300
00816555020581AMP1000/COC300/MET500/OPI300/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020574AMP1000/COC300/MET500/OPI300/THC50
00816555020567COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020550COC300/MET500/OPI2000/PCP25/THC50
00816555020543AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020536AMP1000/COC300/OPI2000/PCP25/THC50
00816555020529COC300/MET500/OPI300/THC50
00816555020512COC300/MET500/THC50 Adulteration Screen for CR/NI/PH/BL/SG
00816555020505THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; BUP10/TCA1000; PCP25/
00816555020499THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 with Cr,
00816555020482THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300 with Cr, Ni, pH, Bl, S.G
00816555020475THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300
00816555020468AMP1000/COC300/BAR300/BZO300/MTD300/OXY100/OPI300 Adulteration Screen for CR-NI-PH-BL-SG
00816555020451AMP1000/COC300/MET1000/PCP25/THC50/OPI2000
00816555020444COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR-NI-PH-BL-SG
00816555020437COC300/MET500/OPI300/THC50/BZO300/OXY100 Adulteration Screen for CR/NI/PH/BL/SG
00816555020420THC50/BZO300/COC300/OPI300/AMP1000/BAR300/MDMA500
00816555020406COC300/MET500/OPI300/THC50/BZO300/MTD300/MDMA500
00816555020383COC300/MET500/OPI300/THC50/BZO300/BAR300/OXY100
00816555020376AMP1000/COC300/MET500/PCP25/THC50/OPI300/MTD300
00816555020369AMP1000/COC300/MET500/PCP25/THC50/OPI2000 Adulteration Screen for CR/NI/PH/BL/SG
00816555020352AMP1000/COC300/MET500/PCP25/THC50/OPI2000
00816555020345COC300/MET500/OPI300/THC50/MTD300/OXY100
00816555020338AMP1000/COC300/MET500/OPI300/THC50/BZO300
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