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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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SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

Pointe Cannabinoid (THC) Reagent Set - 00811727017253

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 - 00811727017246

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)

EXPLORO Highly Sensitive THC Test - 06974246461304

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461304 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460970

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
50 tests
In Commercial Distribution

  • 06974246460970 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460963

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
20 tests
In Commercial Distribution

  • 06974246460963 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460956

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246460956 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460949

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
3 tests
In Commercial Distribution

  • 06974246460949 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460772

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460772 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

OPI/COC/THC Tests Panel - 06952804801946

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

CEDIA THC OFT Negative Calibrator - 00884883005730

No Description
Microgenics Corporation
10014922
In Commercial Distribution

  • 00884883005730 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator

CEDIA THC OFT Cutoff Calibrator - 00884883005723

No Description
Microgenics Corporation
10014923
In Commercial Distribution

  • 00884883005723 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator

CEDIA THC OFT Controls Kit - 00884883005709

No Description
Microgenics Corporation
10014925
In Commercial Distribution

  • 00884883005709 ()


  • Cannabinoid/cannabinoid metabolite IVD, control

TOX/See - 00847817000591

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 - 00847817000379

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

N/A - 00850019007541

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

N/A - 00850019007404

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 - 00850019007114

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 - 00850019007077

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 - 00850019007060

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

Generic - 00850019007961

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

Easy@Home Multi-Drug Screen Test (100 tests kit) - 00850253007994

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

Easy@Home Multi-Drug Screen Test (50 tests kit) - 00850253007987

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

Easy@Home Multi-Drug Screen Test (15 tests kit) - 00850253007895

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

Easy@Home Multi-Drug Screen Test (10 tests kit) - 00850253007888

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

Easy@Home Multi-Drug Screen Test (5 tests kit) - 00850253007871

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 - 00850557007409

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

Easy@Home Multi-Drug Test Cup (25 tests kit) - 00850253007543

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

Easy@Home Multi-Drug Test Cup (5 tests kit) - 00850253007536

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

Easy@Home Multi-Drug Screen Test (25 tests kit) - 00850253007307

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

DrugSmart Cup - 00859144006207

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

DrugSmart Cup - 00859144006191

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

DrugSmart Cup - 00859144006184

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

ProScreen - 00858998006500

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

ProScreen - 00858998006814

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

ProScreen - 00858998006807

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

ProScreen - 00858998006791

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

ProScreen - 00858998006784

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

ProScreen - 00858998006777

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

ProScreen - 00858998006722

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

NexScreen Cup - 00858984006019

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

NexScreen Cup - 00858984006002

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 - 00842768001352

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 - 00842768001307

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 - 00812203030636

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

Oral Fluid Cannabinoid Calibrator, Negative Calibrator - B076S0072C0

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

Advin Multi-Drug Screen Test - B115ABCUP10201

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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