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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CO2 (Carbon Dioxide) w/ cal 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-313
In Commercial Distribution

  • 00817302022049 ()

  • Total Volume: 52 Milliliter
  • Kit contains 3 R1, 1 calibrator, 1 reagent package insert and 1 calibrator package insert
  • Total Volume: 10 Milliliter
AU-313

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
CO2 (Carbon Dioxide) w/ cal 4 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST313
In Commercial Distribution

  • 00817302022032 ()

  • Kit contains 4 R1, 1 calibrator, 1 reagent package insert and 1 calibrator package insert
  • Total Volume: 10 Milliliter
  • Total Volume: 52 Milliliter
ST313

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
CO2 (Carbon Dioxide) w/ cal 3 x 140 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL313
In Commercial Distribution

  • 00817302022025 ()

  • Total Volume: 10 Milliliter
  • Total Volume: 40 Milliliter
  • Kit contains 3 R1, 1 calibrator, 1 reagent package insert and 1 calibrator package insert
BL313

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
XTSY (Ecstasy) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT423
In Commercial Distribution

  • 00817302022018 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT423

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
XTSY (Ecstasy) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL423
In Commercial Distribution

  • 00817302022001 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
BL423

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
XTSY (Ecstasy) 2 x 625 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-423
In Commercial Distribution

  • 00817302021998 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-423

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
XTSY (Ecstasy) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST423
In Commercial Distribution

  • 00817302021974 ()

  • Total Volume: 63 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 26 Milliliter
ST423

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
THC (Cannabinoid) 50 ng/mL 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT410
In Commercial Distribution

  • 00817302021950 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT410

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
PROX (Propoxyphene) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT416
In Commercial Distribution

  • 00817302021943 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT416

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
PCP (Phencyclidine) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT414
In Commercial Distribution

  • 00817302021936 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT414

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
OXYC (Oxycodone) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT419
In Commercial Distribution

  • 00817302021929 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT419

  • Oxycodone IVD, kit, rapid ICT, clinical
OXYC (Oxycodone)
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL419B
In Commercial Distribution

  • 00817302021912 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
BL419B

  • Oxycodone IVD, kit, rapid ICT, clinical
OXYC (Oxycodone) 2 x 625 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-419B
In Commercial Distribution

  • 00817302021905 ()

  • Total Volume: 60 Milliliter
  • Total Volume: 23 Milliliter
  • Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert
AU-419B

  • Oxycodone IVD, kit, rapid ICT, clinical
OXYC (Oxycodone) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST319B
In Commercial Distribution

  • 00817302021899 ()

  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
ST319B

  • Oxycodone IVD, kit, rapid ICT, clinical
OXYC (Oxycodone) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST419B
In Commercial Distribution

  • 00817302021882 ()

  • Total Volume: 26 Milliliter
  • Total Volume: 63 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
ST419B

  • Oxycodone IVD, kit, rapid ICT, clinical
OP (Opiates) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT411
In Commercial Distribution

  • 00817302021875 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT411

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
ETHA (Alcohol) w/ cal 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT421
In Commercial Distribution

  • 00817302021851 ()

  • Total Volume: 46.5 Milliliter
  • Total Volume: 5 Milliliter
  • Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert
DT421

  • Ethanol (ETOH) IVD, kit, spectrophotometry
COCM (Cocaine) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT413
In Commercial Distribution

  • 00817302021844 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT413

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
THC (Cannabinoid) 50 ng/mL CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC410A
Not in Commercial Distribution

  • 00817302021769 ()

  • Kit contains 1 reagent cartridge and 1 package insert
  • Total Volume: 65 Milliliter
  • Total Volume: 18 Milliliter
CC410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
OP (Opiates) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST411A
In Commercial Distribution

  • 00817302021547 ()

  • Total Volume: 63 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 26 Milliliter
ST411A

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
OP (Opiates) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR411A
In Commercial Distribution

  • 00817302021530 ()

  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
MR411A

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
METH (Methamphetamine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT427
In Commercial Distribution

  • 00817302021523 ()

  • Total Volume: 29 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 69 Milliliter
DT427

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
METH (Methamphetamine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-427
Not in Commercial Distribution

  • 00817302021516 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-427

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
METH (Methamphetamine) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST427
In Commercial Distribution

  • 00817302021493 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 26 Milliliter
  • Total Volume: 63 Milliliter
ST427

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
METD (Methadone) CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC415
Not in Commercial Distribution

  • 00817302021462 ()

  • Total Volume: 18 Milliliter
  • Total Volume: 65 Milliliter
  • Kit contains 1 reagent cartridge and 1 package insert
CC415

  • Methadone IVD, kit, enzyme immunoassay (EIA)
METD (Methadone) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST315
In Commercial Distribution

  • 00817302021431 ()

  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 33 Milliliter
ST315

  • Methadone IVD, kit, enzyme immunoassay (EIA)
METD (Methadone) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST415
In Commercial Distribution

  • 00817302021424 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 26 Milliliter
  • Total Volume: 63 Milliliter
ST415

  • Methadone IVD, kit, enzyme immunoassay (EIA)
METD (Methadone) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR415
In Commercial Distribution

  • 00817302021417 ()

  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
MR415

  • Methadone IVD, kit, enzyme immunoassay (EIA)
ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC421
Not in Commercial Distribution

  • 00817302021387 ()

  • Total Volume: 5 Milliliter
  • Total Volume: 32 Milliliter
  • Kit contains 2 Reagent cartridges, 1 Calibrator and 1 package insert
  • Total Volume: 11 Milliliter
CC421

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
ETHA (Alcohol) w/ cal 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR421
In Commercial Distribution

  • 00817302021332 ()

  • Total Volume: 5 Milliliter
  • Total Volume: 20 Milliliter
  • Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert
  • Total Volume: 10 Milliliter
MR421

  • Ethanol (ETOH) IVD, kit, spectrophotometry
COCM (Cocaine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-413
In Commercial Distribution

  • 00817302021257 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 60 Milliliter
  • Total Volume: 23 Milliliter
AU-413

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
COCM (Cocaine) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST113
In Commercial Distribution

  • 00817302021233 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
ST113

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
BUP (Buprenorphine) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR424
In Commercial Distribution

  • 00817302021202 ()

  • Total Volume: 10 Milliliter
  • Total Volume: 20 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
MR424

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
BENZ (Benzodiazepines)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-418
In Commercial Distribution

  • 00817302021189 ()

  • Total Volume: 23 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 60 Milliliter
AU-418

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
BENZ (Benzodiazepines) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST318
In Commercial Distribution

  • 00817302021165 ()

  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 33 Milliliter
ST318

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
BENZ (Benzodiazepines) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST418
In Commercial Distribution

  • 00817302021158 ()

  • Total Volume: 26 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 63 Milliliter
ST418

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
BENZ (Benzodiazepines) 2 X 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR418
In Commercial Distribution

  • 00817302021141 ()

  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
MR418

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates)CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC417
Not in Commercial Distribution

  • 00817302021134 ()

  • Total Volume: 65 Milliliter
  • Kit contains 1 reagent cartridge and 1 package insert
  • Total Volume: 18 Milliliter
CC417

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-417
In Commercial Distribution

  • 00817302021127 ()

  • Total Volume: 23 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 60 Milliliter
AU-417

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL417
In Commercial Distribution

  • 00817302021110 ()

  • Total Volume: 20 Milliliter
  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
BL417

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST317
In Commercial Distribution

  • 00817302021103 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
ST317

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST417
In Commercial Distribution

  • 00817302021097 ()

  • Total Volume: 26 Milliliter
  • Total Volume: 63 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
ST417

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
BARB (Barbiturates) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR417
In Commercial Distribution

  • 00817302021080 ()

  • Total Volume: 20 Milliliter
  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
MR417

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC412
Not in Commercial Distribution

  • 00817302021073 ()

  • Total Volume: 65 Milliliter
  • Total Volume: 18 Milliliter
  • Kit contains 1 reagent cartridge and 1 package insert
CC412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-412
In Commercial Distribution

  • 00817302021066 ()

  • Total Volume: 60 Milliliter
  • Total Volume: 23 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL412
In Commercial Distribution

  • 00817302021059 ()

  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
BL412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST312
In Commercial Distribution

  • 00817302021042 ()

  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
ST312

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST412
In Commercial Distribution

  • 00817302021035 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 63 Milliliter
  • Total Volume: 26 Milliliter
ST412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
AMPH (Amphetamines) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR412
In Commercial Distribution

  • 00817302021028 ()

  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 20 Milliliter
MR412

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
6AM (6-Acetylmorphine) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR425
In Commercial Distribution

  • 00817302021011 ()

  • Total Volume: 20 Milliliter
  • Total Volume: 10 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
MR425

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
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