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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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CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 - 00817302020540

CREA (Creatinine) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-243
In Commercial Distribution

  • 00817302020540 ()

  • Total Volume: 45 Milliliter
  • Total Volume: 11 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
AU-243

  • Creatine IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® C02 ALK Buffer 88813 - 00817302020533

CO2 (Carbon Dioxide) Alkaline w/ cal - Modular & CX3 Reagent 1 x 500 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88813
In Commercial Distribution

  • 00817302020533 ()

  • Total Volume: 500 Milliliter
  • Kit contains 1 R1 and 1 package insert
88813

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)

CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812 - 00817302020526

CO2 (Carbon Dioxide) Acid w/ cal - Modular & CX3 Reagent 1 x 2000 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88812
In Commercial Distribution

  • 00817302020526 ()

  • Kit contains 1 R1 and 1 package insert
  • Total Volume: 2000 Milliliter
88812

  • Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)

CAROLINA LIQUID CHEMISTRIES CORP.™ CK CREATINE KINASE REAGENT CC207 - 00817302020519

CK (Creatine Kinase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC207
In Commercial Distribution

  • 00817302020519 ()

  • Total Volume: 60 Milliliter
  • Total Volume: 10 Milliliter
  • Kit contains 2 reagent cartridges and 1 package insert
CC207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® CK RGT. KIT AU-207 - 00817302020502

CK (Creatine Kinase) 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-207
In Commercial Distribution

  • 00817302020502 ()

  • Total Volume: 35 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 9 Milliliter
AU-207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207 - 00817302020489

CK (Creatine Kinase) 4 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST207
In Commercial Distribution

  • 00817302020489 ()

  • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
  • Total Volume: 56 Milliliter
  • Total Volume: 17 Milliliter
ST207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 3 CC910 - 00817302020472

Cal Level 3 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC910
In Commercial Distribution

  • 00817302020472 ()

  • Total Volume: 25 Milliliter
  • Kit contains 6 R1 bottles and 1 package insert
CC910

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909 - 00817302020465

Cal Level 2 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC909
In Commercial Distribution

  • 00817302020465 ()

  • Total Volume: 25 Milliliter
  • Kit contains 6 R1 bottles and 1 package insert
CC909

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 1 CC908 - 00817302020458

Cal Level 1 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6x 25 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC908
In Commercial Distribution

  • 00817302020458 ()

  • Kit contains 6 R1 bottles and 1 package insert
  • Total Volume: 25 Milliliter
CC908

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

CAROLINA LIQUID CHEMISTRIES CORP.™ CA CALCIUM REAGENT CC251 - 00817302020434

CA (Calcium) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC251
In Commercial Distribution

  • 00817302020434 ()

  • Total Volume: 101 Milliliter
  • Kit contains 1 R1 bottle and 1 package insert
CC251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT AU-251 - 00817302020427

CA (Calcium) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-251
In Commercial Distribution

  • 00817302020427 ()

  • Kit contains 1 R1 bottle and 1 package insert
  • Total Volume: 60 Milliliter
AU-251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT BL-251 - 00817302020410

CA (Calcium) 3 x 160 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL251
In Commercial Distribution

  • 00817302020410 ()

  • Total Volume: 40 Milliliter
  • Kit contains 1 R1 bottle and 1 package insert
BL251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251 - 00817302020403

CA (Calcium) 4 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST251
In Commercial Distribution

  • 00817302020403 ()

  • Kit contains 1 R1 bottle and 1 package insert
  • Total Volume: 57 Milliliter
ST251

  • Calcium (Ca2+) IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.™ BUN REAGENT 88806 - 00817302020397

BUN3 (Blood Urea Nitrogen) - CX3 Reagent 1 x 500 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88806
In Commercial Distribution

  • 00817302020397 ()

  • Total Volume: 500 Milliliter
  • Kit contains 1 R1 bottle and 1 package insert
88806

  • Urea IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252 - 00817302020373

BUN (Blood Urea Nitrogen) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-252
In Commercial Distribution

  • 00817302020373 ()

  • Total Volume: 60 Milliliter
  • Kit contains 3 R1/R2 bottles and 1 package insert
AU-252

  • Urea IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT BL-252 - 00817302020366

BUN (Blood Urea Nitrogen) 3 x 170 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL252
In Commercial Distribution

  • 00817302020366 ()

  • Kit contains 3 R1/R2 bottles and 1 package insert
  • Total Volume: 40 Milliliter
BL252

  • Urea IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 BUN REAGENT KIT Product No. ST252 - 00817302020359

BUN (Blood Urea Nitrogen) 4 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST252
In Commercial Distribution

  • 00817302020359 ()

  • Kit contains 4 R1/R2 bottles and 1 package insert
  • Total Volume: 49 Milliliter
ST252

  • Urea IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.™ AST REAGENT CC241 - 00817302020342

AST (Aspartate Aminotransferase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC241
In Commercial Distribution

  • 00817302020342 ()

  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 60 Milliliter
  • Total Volume: 10 Milliliter
CC241

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT AU-241 - 00817302020335

AST (Aspartate Aminotransferase) 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-241
In Commercial Distribution

  • 00817302020335 ()

  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 44 Milliliter
  • Total Volume: 8 Milliliter
AU-241

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT BL-241 - 00817302020328

AST (Aspartate Aminotransferase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL241
In Commercial Distribution

  • 00817302020328 ()

  • Total Volume: 5 Milliliter
  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 25 Milliliter
BL241

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AST RGT KIT Product No. ST241 - 00817302020311

AST (Aspartate Aminotransferase) 4 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST241
In Commercial Distribution

  • 00817302020311 ()

  • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
  • Total Volume: 8 Milliliter
  • Total Volume: 48 Milliliter
ST241

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227 - 00817302020304

AMY (Amylase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC227
In Commercial Distribution

  • 00817302020304 ()

  • Total Volume: 60 Milliliter
  • Kit contains 2 reagent cartridges, 1 package insert and user defined parameters
CC227

  • Amylase isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227 - 00817302020281

AMY (Amylase) 3 x 170 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL227
In Commercial Distribution

  • 00817302020281 ()

  • Total Volume: 40 Milliliter
  • Kit contains 3 R1 bottles and 1 package insert
BL227

  • Amylase isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 - 00817302020274

AMY (Amylase) 4 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST227
In Commercial Distribution

  • 00817302020274 ()

  • Kit contians 4 R1 bottles and 1 package insert
  • Total Volume: 53 Milliliter
ST227

  • Amylase isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® ALP ALKALINE PHOSPHATASE REAGENT CC206 - 00817302020267

ALP (Alkaline Phosphatase) 2 x 200 tests .
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC206
In Commercial Distribution

  • 00817302020267 ()

  • Total Volume: 60 Milliliter
  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 10 Milliliter
CC206

  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT BL-206 - 00817302020250

ALP (Alkaline Phosphatase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL206
In Commercial Distribution

  • 00817302020250 ()

  • Total Volume: 25 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 5 Milliliter
BL206

  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® ALP RGT.KIT AU-206 - 00817302020243

ALP (Alkaline Phosphatase) 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-206
In Commercial Distribution

  • 00817302020243 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 57 Milliliter
AU-206

  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALP RGT KIT Product No. ST206 - 00817302020236

ALP (Alkaline Phosphatase) 4 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST206
In Commercial Distribution

  • 00817302020236 ()

  • Total Volume: 7.5 Milliliter
  • Kit contains 4 R1 and 4 R2 bottles and 1 package insert.
  • Total Volume: 59 Milliliter
ST206

  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 - 00817302020229

ALB (Albumin) BCP 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC214
In Commercial Distribution

  • 00817302020229 ()

  • Kit contains 2 reagent cartridges 1 reagent package insert
  • Total Volume: 101 Milliliter
CC214

  • Albumin IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224 - 00817302020212

ALB (Albumin) BCG (UDR) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC224
In Commercial Distribution

  • 00817302020212 ()

  • Kit contains 2 reagent cartridges 1 reagent package insert
  • Total Volume: 101 Milliliter
CC224

  • Albumin IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224 - 00817302020205

ALB (Albumin) 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-224
In Commercial Distribution

  • 00817302020205 ()

  • Kit contains 3 R1 bottles and 1 package insert
  • Total Volume: 60 Milliliter
AU-224

  • Albumin IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224 - 00817302020199

ALB (Albumin) 4 x 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST224
In Commercial Distribution

  • 00817302020199 ()

  • Total Volume: 53 Milliliter
  • Kit contains 4 R1 bottles and 1 package insert
ST224

  • Albumin IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224 - 00817302020182

ALB (Albumin) 3 X 160 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL-224.
In Commercial Distribution

  • 00817302020182 ()

  • Total Volume: 40 Milliliter
  • Kit contains 3R1 bottles and 1 package insert
BL-224.

  • Albumin IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D - 00817302020151

Lp(a) (Lipoprotein (a) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC204-100-D
In Commercial Distribution

  • 00817302020151 ()

  • Kit contains 2 reagent cartridges 1 reagent package insert and 1 user defined parameters package insert
  • Total Volume: 4 Milliliter
  • Total Volume: 15 Milliliter
CC204-100-D

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D - 00817302020144

Lp(a) (Lipoprotein (a) 3 x 400 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-204-D
In Commercial Distribution

  • 00817302020144 ()

  • Total Volume: 15 Milliliter
  • Total Volume: 45 Milliliter
  • Kit contains 3 R1 bottles, 3 R2 bottles and 1 package insert
AU-204-D

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 - 00817302020137

Lp(a) (Lipoprotein (a) 2 x 130 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL204
In Commercial Distribution

  • 00817302020137 ()

  • Total Volume: 7 Milliliter
  • Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert
  • Total Volume: 18 Milliliter
BL204

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 - 00817302020120

HCY (Homocysteine) w/ cal 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC202
In Commercial Distribution

  • 00817302020120 ()

  • Total Volume: 5 Milliliter
  • Total Volume: 2.5 Milliliter
  • Total Volume: 20 Milliliter
  • Kit contains 2 HCY Reagent cartridges, 1 C1 Calibrator, 1 C2 Calibrator,1 Reagent Kit Package insert and 2 User Defined Parameters
CC202

  • Homocysteine IVD, control

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 - 00817302020113

HCY (Homocysteine) Level 3 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC053
In Commercial Distribution

  • 00817302020113 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC053

  • Homocysteine IVD, control

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 - 00817302020106

HCY (Homocysteine) Level 2 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC052
In Commercial Distribution

  • 00817302020106 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC052

  • Homocysteine IVD, control

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 - 00817302020090

HCY (Homocysteine) Level 1 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC051
In Commercial Distribution

  • 00817302020090 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC051

  • Homocysteine IVD, control
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