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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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ALPT23 08 - B800ALPT23080

ALPT23 08
UTAK LABORATORIES, INC.
ALPT23_08
In Commercial Distribution

  • B800ALPT23085 ()
  • B800ALPT23080 ()

  • Total Volume: 1 Milliliter
ALPT23_08

  • Multiple-type clinical chemistry analyte profile IVD, control

ALPT23 07 - B800ALPT23070

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

ALPT23 06 - B800ALPT23060

ALPT23 06
UTAK LABORATORIES, INC.
ALPT23_06
In Commercial Distribution

  • B800ALPT23065 ()
  • B800ALPT23060 ()

  • Total Volume: 1 Milliliter
ALPT23_06

  • Multiple-type clinical chemistry analyte profile IVD, control

ALPRAZOLAM PLUS - B800ALPRUFBRL0

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 - B800ALP3V2UFUK0

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 - B800ALP3V2UFLENCO0

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 - B800ALP2V2UFUK0

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 - B800ALP2V2UFLENCO0

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 - B800ALP1V2UFLENCO0

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 - B800ALDO3FUVHS0

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 - B800ALD2UFLC0

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 - B800AFUNGL3SFMAYO0

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 - B800AFUNGL2SFUW0

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 - B800AFUNGL2SFMAYO0

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 - B800AFUNGL1SFMAYO0

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

B80088121SFA100MLF0 - B80088121SFA100MLF0

B80088121SFA100MLF0
UTAK LABORATORIES, INC.
88121-SFA(100ML-F)
In Commercial Distribution

  • B80088121SFA100MLF5 ()
  • B80088121SFA100MLF0 ()

  • Total Volume: 100 Milliliter
88121-SFA(100ML-F)

  • Multiple-type clinical chemistry analyte profile IVD, control

CERTIFIED DRUG FREE URINE - B80088121CDFF10FS0

CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
88121-CDF(F)10 FS
In Commercial Distribution

  • B80088121CDFF10FS5 ()
  • B80088121CDFF10FS0 ()

  • Total Volume: 10 Milliliter
88121-CDF(F)10 FS

  • Multiple-type clinical chemistry analyte profile IVD, control

Certified Drug Free Urine (Frozen) - B8008812110

Certified Drug Free Urine (Frozen)
UTAK LABORATORIES, INC.
88121-CDF(F)
In Commercial Distribution

  • B8008812110 ()

  • Total Volume: 835 Milliliter
88121-CDF(F)

  • Multiple therapeutic drugs/drugs of abuse IVD, control

SAMHSA Confirm Level 2 - B800818210

SAMHSA Confirm Level 2 (SMx OF)
UTAK LABORATORIES, INC.
81821
In Commercial Distribution

  • B800818215 ()
  • B800818210 ()

  • Total Volume: 3 Milliliter
81821

  • Multiple drugs of abuse IVD, control

SAMHSA Confirm Level 1 - B800818200

SAMHSA Confirm Level 1 (SMx OF)
UTAK LABORATORIES, INC.
81820
In Commercial Distribution

  • B800818205 ()
  • B800818200 ()

  • Total Volume: 3 Milliliter
81820

  • Multiple drugs of abuse IVD, control

7-AMINOS PLUS LOW - B8007AMINOLUFDU0

7-AMINOS PLUS LOW
UTAK LABORATORIES, INC.
7-AMINO+ L U F DU
In Commercial Distribution

  • B8007AMINOLUFDU5 ()
  • B8007AMINOLUFDU0 ()

  • Total Volume: 1 Milliliter
7-AMINO+ L U F DU

  • Multiple-type clinical chemistry analyte profile IVD, control

7-AMINOCLONAZEPAM LOW - B8007AMINOLOWUPM0

7-AMINOCLONAZEPAM LOW
UTAK LABORATORIES, INC.
7-AMINO LOW UPM
In Commercial Distribution

  • B8007AMINOLOWUPM5 ()
  • B8007AMINOLOWUPM0 ()

  • Total Volume: 1 Milliliter
7-AMINO LOW UPM

  • Multiple drugs of abuse IVD, control

7-AMINOCLONAZEPAM LOW - B8007AMINOLOWMDL0

7-AMINOCLONAZEPAM LOW
UTAK LABORATORIES, INC.
7-AMINO LOW MDL
In Commercial Distribution

  • B8007AMINOLOWMDL5 ()
  • B8007AMINOLOWMDL0 ()

  • Total Volume: 1 Milliliter
7-AMINO LOW MDL

  • Multiple-type clinical chemistry analyte profile IVD, control

7-AMINOCLONAZEPAM HIGH - B8007AMINOHIGHUPM0

7-AMINOCLONAZEPAM LOW
UTAK LABORATORIES, INC.
7-AMINO HIGH UPM
In Commercial Distribution

  • B8007AMINOHIGHUPM5 ()
  • B8007AMINOHIGHUPM0 ()

  • Total Volume: 1 Milliliter
7-AMINO HIGH UPM

  • Multiple drugs of abuse IVD, control

7-AMINOCLONAZEPAM HIGH - B8007AMINOHIGHMDL0

7-AMINOCLONAZEPAM HIGH
UTAK LABORATORIES, INC.
7-AMINO HIGH MDL
In Commercial Distribution

  • B8007AMINOHIGHMDL5 ()
  • B8007AMINOHIGHMDL0 ()

  • Total Volume: 1 Milliliter
7-AMINO HIGH MDL

  • Multiple-type clinical chemistry analyte profile IVD, control

6-MONOACETYLMORPHINE LEVEL 3 - B8006MAM3OFNAVIS0

6-MONOACETYLMORPHINE LEVEL 3
UTAK LABORATORIES, INC.
6-MAM 3 OF NAVIS
In Commercial Distribution

  • B8006MAM3OFNAVIS5 ()
  • B8006MAM3OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 3 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control

6-MONOACETYLMORPHINE LEVEL 2 - B8006MAM2OFNAVIS0

6-MONOACETYLMORPHINE LEVEL 2
UTAK LABORATORIES, INC.
6-MAM 2 OF NAVIS
In Commercial Distribution

  • B8006MAM2OFNAVIS5 ()
  • B8006MAM2OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 2 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control

6-MONOACETYLMORPHINE LEVEL 1 - B8006MAM1OFNAVIS0

6-MONOACETYLMORPHINE LEVEL 1
UTAK LABORATORIES, INC.
6-MAM 1 OF NAVIS
In Commercial Distribution

  • B8006MAM1OFNAVIS5 ()
  • B8006MAM1OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 1 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control

NORMAL RANGE TRACE ELEMENTS V3 - B80066816V3NRLC0

NORMAL RANGE TRACE ELEMENTS V3
UTAK LABORATORIES, INC.
66816 V3 NR LC
In Commercial Distribution

  • B80066816V3NRLC5 ()
  • B80066816V3NRLC0 ()

  • Total Volume: 5 Milliliter
66816 V3 NR LC

  • Multiple-type clinical chemistry analyte profile IVD, control

NORMAL RANGE TRACE ELEMENTS - B80066816V2NRLC0

NORMAL RANGE TRACE ELEMENTS
UTAK LABORATORIES, INC.
66816 V2 NR LC
In Commercial Distribution

  • B80066816V2NRLC5 ()
  • B80066816V2NRLC0 ()

  • Total Volume: 5 Milliliter
66816 V2 NR LC

  • Multiple-type clinical chemistry analyte profile IVD, control

HIGH RANGE TRACE ELEMENTS V3 - B80066815V3HRLC0

HIGH RANGE TRACE ELEMENTS V3
UTAK LABORATORIES, INC.
66815 V3 HR LC
In Commercial Distribution

  • B80066815V3HRLC5 ()
  • B80066815V3HRLC0 ()

  • Total Volume: 5 Milliliter
66815 V3 HR LC

  • Multiple-type clinical chemistry analyte profile IVD, control

HIGH RANGE TRACE ELEMENTS - B80066815V2HRLC0

66815 V2 HR LC
UTAK LABORATORIES, INC.
66815 V2 HR LC
In Commercial Distribution

  • B80066815V2HRLC5 ()
  • B80066815V2HRLC0 ()

  • Total Volume: 5 Milliliter
66815 V2 HR LC

  • Multiple-type clinical chemistry analyte profile IVD, control

DHEA Plus Low - B800514100

DHEA Plus Low
UTAK LABORATORIES, INC.
51410
In Commercial Distribution

  • B800514105 ()
  • B800514100 ()

  • Total Volume: 3 Milliliter


  • Multiple steroid hormone IVD, control

Steroids Level 4 (SMx Serum) - B800514040

Steroids Level 4 (SMx Serum)
UTAK LABORATORIES, INC.
51404
In Commercial Distribution

  • B800514045 ()
  • B800514040 ()

  • Total Volume: 3 Milliliter
51404

  • Multiple steroid hormone IVD, control

Steroids Level 1 (SMx Serum) - B800514010

Steroids Level 1 (SMx Serum)
UTAK LABORATORIES, INC.
51401
In Commercial Distribution

  • B800514015 ()
  • B800514010 ()

  • Total Volume: 3 Milliliter
51401

  • Multiple steroid hormone IVD, control

BLANK WHOLE BLOOD - B80044600WBF9500

No Description
UTAK LABORATORIES, INC.
44600-WB(F)950
In Commercial Distribution

  • B80044600WBF9500 ()

  • Total Volume: 950 Milliliter
44600-WB(F)950

  • Multiple therapeutic drugs/drugs of abuse IVD, control

BLANK WHOLE BLOOD 50 ML - B80044600WBF50UK0

BLANK WHOLE BLOOD 50 ML
UTAK LABORATORIES, INC.
44600-WB(F)50 UK
In Commercial Distribution

  • B80044600WBF50UK5 ()
  • B80044600WBF50UK0 ()

  • Total Volume: 50 Milliliter
44600-WB(F)50 UK

  • Multiple-type clinical chemistry analyte profile IVD, control

BLANK WHOLE BLOOD - B80044600WBF5000

BLANK WHOLE BLOOD
UTAK LABORATORIES, INC.
44600-WB(F)500
In Commercial Distribution

  • B80044600WBF5000 ()

  • Total Volume: 500 Milliliter
44600-WB(F)500

  • Multiple therapeutic drugs/drugs of abuse IVD, control

DEFIBRINATED PLASMA - B80044600DAL100

DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
44600-DAL10
In Commercial Distribution

  • B80044600DAL105 ()
  • B80044600DAL100 ()

  • Total Volume: 10 Milliliter
44600-DAL10

  • Multiple-type clinical chemistry analyte profile IVD, control

Blank Whole Blood - B8004460030

Blank Whole Blood (Frozen)
UTAK LABORATORIES, INC.
44600-WB(F)
In Commercial Distribution

  • B8004460030 ()

  • Total Volume: 250 Milliliter
44600-WB(F)

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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