DrugSmart Cup 13

GUDID 00850019007626

DrugSmart Cup 13 CLIA-Waived Test, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA/BUP, 25tests/kit

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00850019007626
NIH Device Record Keybb533e07-63cd-4a3f-9873-826918032cf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugSmart Cup 13
Version Model NumberC-61313D
Company DUNS795658603
Company NameCHEMTRON BIOTECH INC
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019007626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

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 Date2016-09-30

Devices Manufactured by CHEMTRON BIOTECH INC

00812203030780 - DrugSmart Cup2024-08-06 DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)
00812203030797 - Generic2024-08-06 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC
00812203030759 - Generic2024-06-05 TML Dip Card Test, 25pcs/kit
00812203030766 - Premier Biotech2024-06-05 10-Panel DOA Cup, AMP500/BUP/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/THC, 25tests/kit
00812203030773 - Premier Biotech2024-06-05 13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC, 25tests/kit
00812203030728 - Generic2024-04-17 11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(Ni/pH/Gl), 25tests/kit
00812203030711 - Generic2024-04-16 12-Panel DOA Dip, AMP/BZO/COC/MTD/MDMA/MET/MOR/OXY/BUP/TML/FYL5/THC
00812203030735 - Premier Biotech2024-04-16 14-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC/TML + A-strip (Ox/SG/pH), 25tests/kit
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