Premier Biotech

GUDID 00812203030582

6 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)

CHEMTRON 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, 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 Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00812203030582
NIH Device Record Key469f9368-731e-476b-a5af-fe21652b59a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Biotech
Version Model NumberPCA-6M2S-20
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100812203030582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-01
Device Publish Date2022-05-24

On-Brand Devices [Premier Biotech]

0081220303031514-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
0081220303049012-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB
0081220303035312-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB
0081220303050610 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
00812203030360Premier Biotech 10-Panel DOA Cup, AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/PCP25/PPX300/
0081220303056810 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/(Cr/Ox/pH)
008122030305756 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
008122030305826 Panel Cup W/ AMP500/COC150/MET500/OPI300/PCP25/THC50(Cr/Ox/pH)
0081220303073514-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MET500/MDMA/MOR/MTD/OXY/PCP/THC/TML + A-strip (

Trademark Results [Premier Biotech]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREMIER BIOTECH
PREMIER BIOTECH
85179692 4085346 Live/Registered
Premier Biotech
2010-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.