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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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U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 12 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BZO/BUP/MDMA/MTD/OXY/PPX)
Instant Technologies, Inc.
USSCupA-12
In Commercial Distribution

USSCupA-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCupA-10M
In Commercial Distribution

USSCupA-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-12BUP300CLIA
In Commercial Distribution

USSCUPA-12BUP30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCup-10M
In Commercial Distribution

USSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Compact Multi-Drug Urine Test Cup <AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000>
Instant Technologies, Inc.
ACDOA-2115
In Commercial Distribution

  • 00817405021031 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801892 ()
MD-U610

  • Methadone IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system (SOLIC *1) that ensures low laser power density on the anterior segment is incorporated. The ZEISS SL130 type is available. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). The ZEISS SL130 type is available: *1 Safety Optics with Low Impact on Cornea
NIDEK CO.,LTD.
GEA01
In Commercial Distribution

  • 04987669101179 ()


  • General/multiple surgical frequency-doubled solid-state laser system
The delivery unit is connected to the YELLOW LASER PHOTOCOAGULATOR YLC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system (SOLIC *1) that ensures low laser power density on the anterior segment is incorporated. The ZEISS SL130 type is available. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). The HAAG BQ900 type type is available: *1 Safety Optics with Low Impact on Cornea
NIDEK CO.,LTD.
GEC01
In Commercial Distribution

  • 04987669101216 ()


  • General/multiple surgical frequency-doubled solid-state laser system
25T, FDA, CLIA WAIVED (AMP500/BAR300/BUP10/BZO300/COC150/FTY1/MDMA500/MET500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50)+(OXI/CRE/pH)
Hangzhou AllTest Biotech Co., Ltd.
DUA-A1147C
In Commercial Distribution

  • 06936983166256 ()
  • 06936983166225 ()
ABTDUAW114705E

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Drug Urine Dip Card ( 12-Panel T-Dip: (AMP,BAR,BZO,COC,MET,MDMA,MOP,MTD,OXY,PCP,TCA,THC), 25Test/ Box
WONDFO USA CO., LTD.
DWDOA-7125-25BX-A
In Commercial Distribution

  • 10816862024781 ()
  • 00816862024784 ()
  • 00816862024777 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-2135A3
In Commercial Distribution

  • 10816862026396 ()
  • 00816862026399 ()
  • 00816862026382 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-2135
In Commercial Distribution

  • 10816862026372 ()
  • 00816862026375 ()
  • 00816862026368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 12-Panel T-Cup Compact; 50 per case; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
DCDOA-3124-50BX-A
In Commercial Distribution

  • 10816862024897 ()
  • 00816862024890 ()
  • 00816862024883 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Drug Urine Test Cup( 12-Panel T-Cup: (AMP,BAR,BZO,COC,MET,MDMA,MOP,MTD,OXY,PCP,TCA,THC), 25Test/ Box
WONDFO USA CO., LTD.
DTDOA-7125-25BX-A
In Commercial Distribution

  • 10816862024743 ()
  • 00816862024746 ()
  • 00816862024739 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC,5 per box
WONDFO USA CO., LTD.
DWDOA-7125-5BX-A
In Commercial Distribution

  • 10816862024439 ()
  • 00816862024432 ()
  • 00816862024449 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW114704D
In Commercial Distribution

  • 30817405023883 ()
  • 00817405023882 ()
  • 10817405023889 ()
ABTDUAW114704D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50
Instant Technologies, Inc.
ABTDOAW114701A
In Commercial Distribution

  • 30817405023876 ()
  • 00817405023875 ()
  • 10817405023872 ()
ABTDOAW114701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 w/ SVT OX/SG/Ph
Instant Technologies, Inc.
ABTDUAW114703C
In Commercial Distribution

  • 30817405023845 ()
  • 00817405023844 ()
  • 10817405023841 ()
ABTDUAW114703C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 PANEL CLIA WAIVED DIP CARD AMP1000,BAR300,BZO300,COC300,MDMA500,MET100,MOP300,MTD300,OXY100,PCP25,TCA1000,THC50
Instant Technologies, Inc.
ABTDOAW112402B
In Commercial Distribution

  • 30817405023586 ()
  • 00817405023585 ()
  • 10817405023582 ()
ABTDOAW112402B

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