Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Customizable medical panel insert capable of being oriented vertically or horizontally to fit inside a variety of backpacks or messenger-style bags via a unique hinge system.
Altitude Technologies Inc.
01246BK
In Commercial Distribution

  • 00850018892049 ()
1246BK

  • First aid kit, non-medicated, single-use
This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (PCP)
CONFIRM BIOSCIENCES, INC.
03-5542
In Commercial Distribution

  • 00895330002073 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections
Luminex Molecular Diagnostics, Inc
I025C0197
Not in Commercial Distribution

  • 00840487100486 ()
I025C0197

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-20124
In Commercial Distribution

  • 20817038022218 ()
  • 10817038022211 ()
  • 00817038022214 ()
U-DOA-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
AALTO SCIENTIFIC
K898M-5
In Commercial Distribution

  • B085K898M50 ()


  • Multiple urine analyte IVD, control
No Description
AALTO SCIENTIFIC
K897M-5
In Commercial Distribution

  • B085K897M50 ()


  • Multiple urine analyte IVD, control
No Description
Bion Enterprises, Ltd.
QRP-6314
Not in Commercial Distribution

  • B110QRP63140 ()
QRP-6314

  • Multiple-genus respiratory virus antigen IVD, control
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-15
In Commercial Distribution

  • M90107RD7073151 ()
  • M90107RD7073150 ()

  • Length: 75 Millimeter
07RD7073-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC / PCP / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-09
In Commercial Distribution

  • M90107RD7073091 ()
  • M90107RD7073090 ()

  • Length: 75 Millimeter
07RD7073-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-08
In Commercial Distribution

  • M90107RD7073081 ()
  • M90107RD7073080 ()

  • Length: 75 Millimeter
07RD7073-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-04
In Commercial Distribution

  • M90107RD7073041 ()
  • M90107RD7073040 ()

  • Length: 75 Millimeter
07RD7073-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-03
In Commercial Distribution

  • M90107RD7073031 ()
  • M90107RD7073030 ()

  • Length: 75 Millimeter
07RD7073-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-01A
In Commercial Distribution

  • M90107RD707301A1 ()
  • M90107RD707301A0 ()

  • Length: 75 Millimeter
07RD7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-01
In Commercial Distribution

  • M90107RD7073011 ()
  • M90107RD7073010 ()

  • Length: 75 Millimeter
07RD7073-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7072-10
In Commercial Distribution

  • M90107RD7072101 ()
  • M90107RD7072100 ()

  • Length: 75 Millimeter
07RD7072-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR/ BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7072-01
In Commercial Distribution

  • M90107RD7072010 ()
  • M90107RD7072011 ()

  • Length: 75 Millimeter
07RD7072-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-20
In Commercial Distribution

  • M90107RD7071201 ()
  • M90107RD7071200 ()

  • Length: 75 Millimeter
07RD7071-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-12
In Commercial Distribution

  • M90107RD7071121 ()
  • M90107RD7071120 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP/ MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-19
In Commercial Distribution

  • M90107RD7070191 ()
  • M90107RD7070190 ()

  • Length: 75 Millimeter
07RD7070-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / MTD / OPI / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-18
In Commercial Distribution

  • M90107RD7070181 ()
  • M90107RD7070180 ()

  • Length: 75 Millimeter
07RD7070-18

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-17
In Commercial Distribution

  • M90107RD7070171 ()
  • M90107RD7070170 ()

  • Length: 75 Millimeter
07RD7070-17

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-15
In Commercial Distribution

  • M90107RD7070151 ()
  • M90107RD7070150 ()

  • Length: 75 Millimeter
07RD7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-14
In Commercial Distribution

  • M90107RD7070141 ()
  • M90107RD7070140 ()

  • Length: 75 Millimeter
07RD7070-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-13
In Commercial Distribution

  • M90107RD7070131 ()
  • M90107RD7070130 ()

  • Length: 75 Millimeter
07RD7070-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-12
In Commercial Distribution

  • M90107RD7070121 ()
  • M90107RD7070120 ()

  • Length: 75 Millimeter
07RD7070-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-11
In Commercial Distribution

  • M90107RD7070111 ()
  • M90107RD7070110 ()

  • Length: 75 Millimeter
07RD7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7070-04
In Commercial Distribution

  • M90107RD7070041 ()
  • M90107RD7070040 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-43
In Commercial Distribution

  • M90107RD7065430 ()
  • M90107RD7065431 ()

  • Length: 75 Millimeter
07RD7065-43

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ BZD / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-42
In Commercial Distribution

  • M90107RD7065421 ()
  • M90107RD7065420 ()

  • Length: 75 Millimeter
07RD7065-42

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-40
In Commercial Distribution

  • M90107RD7065401 ()
  • M90107RD7065400 ()

  • Length: 75 Millimeter
07RD7065-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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