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

Show Filters

ALUMINUM LEVEL 2
UTAK LABORATORIES, INC.
ALUM 2 S BP
In Commercial Distribution

  • B800ALUM2SBP5 ()
  • B800ALUM2SBP0 ()

  • Total Volume: 3 Milliliter
ALUM 2 S BP

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 09
UTAK LABORATORIES, INC.
ALPT23_ETOH 09
In Commercial Distribution

  • B800ALPT23ETOH095 ()
  • B800ALPT23ETOH090 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 09

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 07
UTAK LABORATORIES, INC.
ALPT23_ETOH 07
In Commercial Distribution

  • B800ALPT23ETOH075 ()
  • B800ALPT23ETOH070 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 07

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 ETOH 06
UTAK LABORATORIES, INC.
ALPT23_ETOH 06
In Commercial Distribution

  • B800ALPT23ETOH065 ()
  • B800ALPT23ETOH060 ()

  • Total Volume: 1.25 Milliliter
ALPT23_ETOH 06

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 09
UTAK LABORATORIES, INC.
ALPT23_09
In Commercial Distribution

  • B800ALPT23095 ()
  • B800ALPT23090 ()

  • Total Volume: 1 Milliliter
ALPT23_09

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPT23 07
UTAK LABORATORIES, INC.
ALPT23_07
In Commercial Distribution

  • B800ALPT23075 ()
  • B800ALPT23070 ()

  • Total Volume: 1 Milliliter
ALPT23_07

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS
UTAK LABORATORIES, INC.
ALPR+ U F BRL
In Commercial Distribution

  • B800ALPRUFBRL5 ()
  • B800ALPRUFBRL0 ()

  • Total Volume: 2 Milliliter
ALPR+ U F BRL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
ALPRAZOLAM PLUS LEVEL 3
UTAK LABORATORIES, INC.
ALP+ 3 V2 U F UK
In Commercial Distribution

  • B800ALP3V2UFUK5 ()
  • B800ALP3V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 3 V2 U F UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 3
UTAK LABORATORIES, INC.
ALP+ 3 V2 U F LENCO
In Commercial Distribution

  • B800ALP3V2UFLENCO5 ()
  • B800ALP3V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 3 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 2
UTAK LABORATORIES, INC.
ALP+ 2 V2 U F UK
In Commercial Distribution

  • B800ALP2V2UFUK5 ()
  • B800ALP2V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 2 V2 U F UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 2
UTAK LABORATORIES, INC.
ALP+ 2 V2 U F LENCO
In Commercial Distribution

  • B800ALP2V2UFLENCO5 ()
  • B800ALP2V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 2 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 1
UTAK LABORATORIES, INC.
ALP+ 1 V2 U F UK
In Commercial Distribution

  • B800ALP1V2UFUK5 ()
  • B800ALP1V2UFUK0 ()

  • Total Volume: 2 Milliliter
ALP+ 1 V2 U F UK

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS LEVEL 1
UTAK LABORATORIES, INC.
ALP+ 1 V2 U F LENCO
In Commercial Distribution

  • B800ALP1V2UFLENCO5 ()
  • B800ALP1V2UFLENCO0 ()

  • Total Volume: 2.5 Milliliter
ALP+ 1 V2 U F LENCO

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 3
UTAK LABORATORIES, INC.
ALDO 3 F UVHS
In Commercial Distribution

  • B800ALDO3FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 3 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALDO 2 F UVHS
In Commercial Distribution

  • B800ALDO2FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 2 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 1
UTAK LABORATORIES, INC.
ALDO 1 F UVHS
In Commercial Distribution

  • B800ALDO1FUVHS5 ()
  • B800ALDO1FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 1 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 3
UTAK LABORATORIES, INC.
ALD 3 U F LC
In Commercial Distribution

  • B800ALD3UFLC5 ()
  • B800ALD3UFLC0 ()

  • Total Volume: 5 Milliliter
ALD 3 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALD 2 U F LC
In Commercial Distribution

  • B800ALD2UFLC5 ()
  • B800ALD2UFLC0 ()

  • Total Volume: 5 Milliliter
ALD 2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS LEVEL 3
UTAK LABORATORIES, INC.
A-FUNG L3 S F UW
In Commercial Distribution

  • B800AFUNGL3SFUW5 ()
  • B800AFUNGL3SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L3 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 3
UTAK LABORATORIES, INC.
A-FUNG L3 S F MAYO
In Commercial Distribution

  • B800AFUNGL3SFMAYO5 ()
  • B800AFUNGL3SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L3 S F MAYO

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F UW
In Commercial Distribution

  • B800AFUNGL2SFUW5 ()
  • B800AFUNGL2SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L2 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F MAYO
In Commercial Distribution

  • B800AFUNGL2SFMAYO5 ()
  • B800AFUNGL2SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L2 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F UW
In Commercial Distribution

  • B800AFUNGL1SFUW6 ()
  • B800AFUNGL1SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L1 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 1
UTAK LABORATORIES, INC.
A-FUNG L1 S F MAYO
In Commercial Distribution

  • B800AFUNGL1SFMAYO5 ()
  • B800AFUNGL1SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L1 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ADS/APS CONTROL SOLUTION V3
UTAK LABORATORIES, INC.
ADS/APSV3CONTFCCO
In Commercial Distribution

  • B800ADSAPSV3CONTFCCO5 ()
  • B800ADSAPSV3CONTFCCO0 ()

  • Total Volume: 25 Milliliter
ADS/APSV3CONTFCCO

  • Multiple-therapy therapeutic drug monitoring IVD, control
ACID PLUS
UTAK LABORATORIES, INC.
ACID+ M TCME
In Commercial Distribution

  • B800ACIDMTCME0 ()
  • B800ACIDMTCME5 ()

  • Total Volume: 50 Milliliter
ACID+ M TCME

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETAMINOPHEN PLUS 2
UTAK LABORATORIES, INC.
ACETA+ V3 2 S F BD
In Commercial Distribution

  • B800ACETAV32SFBD5 ()
  • B800ACETAV32SFBD0 ()

  • Total Volume: 4 Milliliter
ACETA+ V3 2 S F BD

  • Multiple drugs of abuse IVD, control
ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0072
In Commercial Distribution

  • 00816784020307 ()
2015-0072

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0071
In Commercial Distribution

  • 00816784020291 ()
2015-0071

  • Hepatitis B virus e-antigen IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0041
In Commercial Distribution

  • 00816784020192 ()
2000-0041

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 51 Multi-Marker Hepatitis 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0040
In Commercial Distribution

  • 00816784020185 ()
2000-0040

  • Hepatitis B virus antigen/antibody marker IVD, control
ACCURUN 31 EBV IgM 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0038
In Commercial Distribution

  • 00816784020161 ()
2000-0038

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
ACCURUN 30 EBV IgG 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0037
In Commercial Distribution

  • 00816784020154 ()
2000-0037

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0063
In Commercial Distribution

  • 00816784020932 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0065
In Commercial Distribution

  • 00816784020925 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2035-0007
In Commercial Distribution

  • 00816784020710 ()
2035-0007

  • PCR/NAT negative control IVD
ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 156 Reagin (Syphilis) 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0094
In Commercial Distribution

  • 00816784020482 ()
2015-0094

  • Treponema pallidum reagin antibody IVD, control
ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0088
In Commercial Distribution

  • 00816784020444 ()
2015-0088

  • Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 141 Rubella IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0086
In Commercial Distribution

  • 00816784020420 ()
2015-0086

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
ACCURUN 136 Toxoplasma IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0083
In Commercial Distribution

  • 00816784020406 ()
2015-0083

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0081
In Commercial Distribution

  • 00816784020383 ()
2015-0081

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-500
In Commercial Distribution

  • 10629009145016 ()


  • Assay development analyte-specific reagent IVD
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-5
In Commercial Distribution

  • 10629009140516 ()


  • Assay development analyte-specific reagent IVD
Positive and Negative Oral Fluid Controls
BRANAN MEDICAL CORPORATION
OC001
Not in Commercial Distribution

  • 00816555020222 ()
OC001

  • Multiple drugs of abuse IVD, calibrator
MassTrak™ Steroid Internal Standard Mix
WATERS TECHNOLOGIES CORPORATION
186010567IVD
In Commercial Distribution

  • 00816776020599 ()
186010567IVD

  • Multiple steroid hormone IVD, control
MassTrak™ Steroid Optimization Mix
WATERS TECHNOLOGIES CORPORATION
186010568IVD
In Commercial Distribution

  • 00816776020582 ()
186010568IVD

  • Multiple steroid hormone IVD, control
< 1 ... 186 187 188 189 190 ... 200 >