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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No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use
Pointe Cannabinoid (THC) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.
POINTE SCIENTIFIC, INC.
60-CA0140-1L
In Commercial Distribution

  • 00811727017253 ()
60-CA0140-1L

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.
POINTE SCIENTIFIC, INC.
60-CA0140-100
In Commercial Distribution

  • 00811727017246 ()
60-CA0140-100

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461304 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
50 tests
In Commercial Distribution

  • 06974246460970 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
20 tests
In Commercial Distribution

  • 06974246460963 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246460956 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
3 tests
In Commercial Distribution

  • 06974246460949 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460772 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801946 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Microgenics Corporation
10014922
In Commercial Distribution

  • 00884883005730 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
10014923
In Commercial Distribution

  • 00884883005723 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
10014925
In Commercial Distribution

  • 00884883005709 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
TOX/See Drug Screen Test AMP, COC, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5200
In Commercial Distribution

  • 00847817000591 ()
1945200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5216
In Commercial Distribution

  • 00847817000379 ()
1945216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, COC/MET/OPI2000/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712E06
In Commercial Distribution

  • 00850019007541 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, AMP/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712E01
In Commercial Distribution

  • 00850019007404 ()
712E01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 5, AMP/COC/MET/OPI/THC, 25pcs/kit
CHEMTRON BIOTECH INC
60500D
In Commercial Distribution

  • 00850019007114 ()
60500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 5, AMP/BAR/COC/OPI2000/THC ,25pcs/kit
CHEMTRON BIOTECH INC
30530D
In Commercial Distribution

  • 00850019007077 ()
30530D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 5, AMP/BAR/BZO/COC/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30510D
In Commercial Distribution

  • 00850019007060 ()
30510D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel DOA Cup, AMP/COC/MET/THC, 25 Tests/kit
CHEMTRON BIOTECH INC
712D01
In Commercial Distribution

  • 00850019007961 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
100 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 00850253007994 ()
  • 30850253007995 ()
  • 10850253007991 ()
EDOAP-144-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
50 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 00850253007987 ()
  • 30850253007988 ()
  • 10850253007984 ()
EDOAP-144-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007892 ()
  • 00850253007895 ()
  • 30850253007896 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007885 ()
  • 00850253007888 ()
  • 30850253007889 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007878 ()
  • 00850253007871 ()
  • 30850253007872 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: THC
MERGERS MARKETING, INC.
PS-THC-114
In Commercial Distribution

  • 10850557007413 ()
  • 00850557007409 ()
  • 00850557007416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
ECDOA-254
In Commercial Distribution

  • 10850253007540 ()
  • 00850253007543 ()
  • 30850253007544 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
ECDOA-254
In Commercial Distribution

  • 10850253007533 ()
  • 00850253007536 ()
  • 30850253007537 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007304 ()
  • 00850253007307 ()
  • 30850253007308 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/MET/OPI drugs of abuse test cup
Twin Spirit Inc.
60500D
Not in Commercial Distribution

  • 00859144006207 ()
60500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/PCP/OPI drugs of abuse test cup
Twin Spirit Inc.
60505D
Not in Commercial Distribution

  • 00859144006191 ()
60505D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/BAR/OPI drugs of abuse test cup
Twin Spirit Inc.
60560D
Not in Commercial Distribution

  • 00859144006184 ()
60560D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSCup-5M-W
Not in Commercial Distribution

  • 00858998006500 ()
PSCup-5M-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
Instant Tech Subsidiary Acquisition
PSD-5N
Not in Commercial Distribution

  • 00858998006814 ()
PSD-5N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, COC/MET1000/OPI2000/PCP/THC
Instant Tech Subsidiary Acquisition
PSD-5MP
Not in Commercial Distribution

  • 00858998006807 ()
PSD-5MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, BZO/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5MB
Not in Commercial Distribution

  • 00858998006791 ()
PSD-5MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5M
Not in Commercial Distribution

  • 00858998006784 ()
PSD-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/BZO/COC/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5AB
Not in Commercial Distribution

  • 00858998006777 ()
PSD-5AB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cassette, (COC/THC)+(MET1000/OPI2000)+AMP
Instant Tech Subsidiary Acquisition
PSP-5M
Not in Commercial Distribution

  • 00858998006722 ()
PSP-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, PCP, OPI drugs of abuse test cup
NEXSCREEN, LLC
60505N
In Commercial Distribution

  • 00858984006019 ()
60505N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, MET, OPI drugs of abuse test cup
NEXSCREEN, LLC
60500N
Not in Commercial Distribution

  • 00858984006002 ()
60500N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC/ mAMP
Siemens Healthcare Diagnostics Inc.
10445364
In Commercial Distribution

  • 00842768001352 ()
  • 00630414013985 ()
6A339UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Siemens Healthcare Diagnostics Inc.
10445359
In Commercial Distribution

  • 00842768001307 ()
  • 00630414013923 ()
6A199UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 5, AMP/COC/MET/OPI2000/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30500D
In Commercial Distribution

  • 00812203030636 ()
30500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 mL/bottle. Concentration: negative (drug-free) OF THC calibrator buffer.
LIN-ZHI INTERNATIONAL, INC.
S0072c
In Commercial Distribution

  • B076S0072C0 ()
S0072c

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP10201 ()
  • B115ABCUP10200 ()
ABCup-10-20

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