SEARCH RESULTS FOR: hibcc(634968 results)

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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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QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software

Spetzler - OMT - M731100020

Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M731100020 ()
  • K900010 ()
  • M7311100149 ()
  • M7311100139 ()
  • M7311100129 ()
  • M7311100119 ()
  • M7311100109 ()
  • M7311100179 ()
  • M731110199 ()
  • M7311100199 ()
ALL

  • Cottonoid pad

StaClear - B994SC250LL0

The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LL Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LL
In Commercial Distribution

  • B994SC250LL0 ()
  • B994SC250LL1 ()
  • B994SC250LL5 ()
  • B994SC250LL2 ()
  • B994SC250LL3 ()
  • B994SC250LL4 ()
  • B994SC250LL6 ()
  • B994SC250LL7 ()

  • Total Volume: 0.25 Milliliter
SC250LL

  • General-purpose syringe/needle

VLGR LEVEL 3 - B80002509000070

No Description
UTAK LABORATORIES, INC.
VLGR 3 S F MAYO
In Commercial Distribution

  • B80002509000070 ()
  • B80002509000071 ()
  • B80002509000072 ()
  • B80002509000073 ()
  • B80002509000076 ()
  • B80002509000077 ()
  • B80002509000078 ()
  • B80002509000079 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

VLGR LEVEL 2 - B80002509000060

No Description
UTAK LABORATORIES, INC.
VLGR 2 S F MAYO
In Commercial Distribution

  • B80002509000060 ()
  • B80002509000061 ()
  • B80002509000062 ()
  • B80002509000063 ()
  • B80002509000066 ()
  • B80002509000067 ()
  • B80002509000068 ()
  • B80002509000069 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

VLGR LEVEL 1 - B80002509000050

No Description
UTAK LABORATORIES, INC.
VLGR 1 S F MAYO
In Commercial Distribution

  • B80002509000050 ()
  • B80002509000051 ()
  • B80002509000052 ()
  • B80002509000053 ()
  • B80002509000056 ()
  • B80002509000057 ()
  • B80002509000058 ()
  • B80002509000059 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

NORMAL HUMAN SERUM - B80002509000040

No Description
UTAK LABORATORIES, INC.
44600-S(MAYO)
In Commercial Distribution

  • B80002509000040 ()
  • B80002509000041 ()
  • B80002509000042 ()
  • B80002509000043 ()
  • B80002509000046 ()
  • B80002509000047 ()
  • B80002509000048 ()
  • B80002509000049 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

ScanX Classic for Intraoral & Extraoral Imaging - D678F37050

ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution

  • D678F37050 ()
  • D678F37001 ()
  • D678F3700U1 ()
  • D678F37051 ()
  • D678F3700C1 ()
  • D678F3750C1 ()
  • D678F37501 ()

  • Height: 24.5 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 51 Pound


  • Radiography digital imaging scanner

StaClear - B994SC250LS0

The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduated barrel with luer slip connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LS Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LS
In Commercial Distribution

  • B994SC250LS2 ()
  • B994SC250LS0 ()
  • B994SC250LS5 ()
  • B994SC250LS7 ()
  • B994SC250LS3 ()
  • B994SC250LS6 ()
  • B994SC250LS8 ()

  • Total Volume: 0.25 Milliliter


  • General-purpose syringe/needle

BUSULFAN QC LEVEL 1 - B80010106500010

No Description
UTAK LABORATORIES, INC.
BUS QC 1 F SHP BHM
In Commercial Distribution

  • B80010106500010 ()
  • B80010106500011 ()
  • B80010106500012 ()
  • B80010106500013 ()
  • B80010106500016 ()
  • B80010106500017 ()
  • B80010106500018 ()


  • Busulfan therapeutic drug monitoring IVD, control

ACETAMINOPHEN PLUS 1 - B80010095200060

No Description
UTAK LABORATORIES, INC.
ACETA+ 1 S F BD
In Commercial Distribution

  • B80010095200061 ()
  • B80010095200060 ()
  • B80010095200062 ()
  • B80010095200063 ()
  • B80010095200066 ()
  • B80010095200067 ()
  • B80010095200068 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

STOCK 3 - B80010095200040

No Description
UTAK LABORATORIES, INC.
STK 3 WB V2 BD 22
In Commercial Distribution

  • B80010095200041 ()
  • B80010095200040 ()
  • B80010095200042 ()
  • B80010095200043 ()
  • B80010095200046 ()
  • B80010095200047 ()
  • B80010095200048 ()


  • Multiple heavy metal IVD, control

ACETAMINOPHEN PLUS HIGH - B80010095200010

No Description
UTAK LABORATORIES, INC.
ACETA+ HIGH V2 S F BD
In Commercial Distribution

  • B80010095200010 ()
  • B80010095200011 ()
  • B80010095200012 ()
  • B80010095200013 ()
  • B80010095200016 ()
  • B80010095200017 ()
  • B80010095200018 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control

DAU CALIBRATOR LEVEL 3 - B80004240000030

No Description
UTAK LABORATORIES, INC.
DAU CAL 3 V4 F SEMCE
In Commercial Distribution

  • B80004240000030 ()
  • B80004240000031 ()
  • B80004240000032 ()
  • B80004240000033 ()
  • B80004240000036 ()
  • B80004240000037 ()
  • B80004240000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DAU CALIBRATOR LEVEL 1 - B80004240000010

No Description
UTAK LABORATORIES, INC.
DAU CAL 1 V4 F SEMCE
In Commercial Distribution

  • B80004240000010 ()
  • B80004240000011 ()
  • B80004240000012 ()
  • B80004240000013 ()
  • B80004240000016 ()
  • B80004240000017 ()
  • B80004240000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

CYSTATHIONINE PLUS LEVEL 2 - B80004000000020

No Description
UTAK LABORATORIES, INC.
CYST+ 2 LC
In Commercial Distribution

  • B80004000000020 ()
  • B80004000000021 ()
  • B80004000000022 ()
  • B80004000000023 ()
  • B80004000000026 ()
  • B80004000000027 ()
  • B80004000000028 ()


  • Multiple vitamin IVD, control

ALUMINUM 18 UG/L - B80003935000010

No Description
UTAK LABORATORIES, INC.
ALUM 18 NR DV
In Commercial Distribution

  • B80003935000010 ()
  • B80003935000011 ()
  • B80003935000012 ()
  • B80003935000013 ()
  • B80003935000016 ()
  • B80003935000017 ()
  • B80003935000018 ()


  • Aluminium IVD, control

ALPRAZOLAM PLUS QC LEVEL 1 - B80003750000050

No Description
UTAK LABORATORIES, INC.
ALP+ QC 1 V3 U F PT
In Commercial Distribution

  • B80003750000051 ()
  • B80003750000050 ()
  • B80003750000052 ()
  • B80003750000053 ()
  • B80003750000056 ()
  • B80003750000057 ()
  • B80003750000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

ALPRAZOLAM PLUS CALIBRATOR LEVEL 4 - B80003750000040

No Description
UTAK LABORATORIES, INC.
ALP+ CAL 4 V3 U F PT
In Commercial Distribution

  • B80003750000040 ()
  • B80003750000041 ()
  • B80003750000042 ()
  • B80003750000043 ()
  • B80003750000046 ()
  • B80003750000047 ()
  • B80003750000048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

ALPRAZOLAM PLUS CALIBRATOR LEVEL 3 - B80003750000030

No Description
UTAK LABORATORIES, INC.
ALP+ CAL 3 V3 U F PT
In Commercial Distribution

  • B80003750000030 ()
  • B80003750000031 ()
  • B80003750000032 ()
  • B80003750000033 ()
  • B80003750000036 ()
  • B80003750000037 ()
  • B80003750000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

ALPRAZOLAM PLUS CALIBRATOR LEVEL 2 - B80003750000020

No Description
UTAK LABORATORIES, INC.
ALP+ CAL 2 V3 U F PT
In Commercial Distribution

  • B80003750000021 ()
  • B80003750000020 ()
  • B80003750000022 ()
  • B80003750000023 ()
  • B80003750000026 ()
  • B80003750000027 ()
  • B80003750000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

ALPRAZOLAM PLUS CALIBRATOR LEVEL 1 - B80003750000010

No Description
UTAK LABORATORIES, INC.
ALP+ CAL 1 V3 U F PT
In Commercial Distribution

  • B80003750000010 ()
  • B80003750000011 ()
  • B80003750000012 ()
  • B80003750000013 ()
  • B80003750000016 ()
  • B80003750000017 ()
  • B80003750000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

BENZODIAZEPINES +25% - B80003716500090

BENZODIAZEPINES +25%
UTAK LABORATORIES, INC.
BENZO +25 PM
In Commercial Distribution

  • B80003716500091 ()
  • B80003716500090 ()
  • B80003716500092 ()
  • B80003716500093 ()
  • B80003716500096 ()
  • B80003716500097 ()
  • B80003716500098 ()


  • Benzodiazepine group IVD, control

DRUGS OF ABUSE QC LEVEL 1 - B80003716500070

DRUGS OF ABUSE QC LEVEL 1
UTAK LABORATORIES, INC.
DA QC 1 OF PM
In Commercial Distribution

  • B80003716500071 ()
  • B80003716500070 ()
  • B80003716500072 ()
  • B80003716500073 ()
  • B80003716500076 ()
  • B80003716500077 ()
  • B80003716500078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

FENTANYL PLUS LEVEL 2 - B80003716500040

FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U PM
In Commercial Distribution

  • B80003716500041 ()
  • B80003716500040 ()
  • B80003716500042 ()
  • B80003716500043 ()
  • B80003716500046 ()
  • B80003716500047 ()
  • B80003716500048 ()


  • Opiate/opiate metabolite IVD, control

FENTANYL PLUS LEVEL 1 - B80003716500030

FENTANYL PLUS LEVEL 1
UTAK LABORATORIES, INC.
FENT+ 1 U PM
In Commercial Distribution

  • B80003716500031 ()
  • B80003716500030 ()
  • B80003716500032 ()
  • B80003716500033 ()
  • B80003716500036 ()
  • B80003716500037 ()
  • B80003716500038 ()


  • Opiate/opiate metabolite IVD, control

4308 LEVEL 2 - B80003716500020

No Description
UTAK LABORATORIES, INC.
430805C08
In Commercial Distribution

  • B80003716500020 ()
  • B80003716500021 ()
  • B80003716500022 ()
  • B80003716500023 ()
  • B80003716500026 ()
  • B80003716500027 ()
  • B80003716500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

4308 LEVEL 1 - B80003716500010

No Description
UTAK LABORATORIES, INC.
430806C08
In Commercial Distribution

  • B80003716500010 ()
  • B80003716500011 ()
  • B80003716500012 ()
  • B80003716500013 ()
  • B80003716500016 ()
  • B80003716500017 ()
  • B80003716500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC V2 LOW - B80002942500100

No Description
UTAK LABORATORIES, INC.
P/Z QC V2 L U F ML
In Commercial Distribution

  • B80002942500101 ()
  • B80002942500100 ()
  • B80002942500102 ()
  • B80002942500103 ()
  • B80002942500106 ()
  • B80002942500107 ()
  • B80002942500108 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

OF QC 3 - B80002942500090

No Description
UTAK LABORATORIES, INC.
QC 3 SMX-OF
In Commercial Distribution

  • B80002942500091 ()
  • B80002942500090 ()
  • B80002942500092 ()
  • B80002942500093 ()
  • B80002942500096 ()
  • B80002942500097 ()
  • B80002942500098 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

OF QC 4 - B80002942500080

No Description
UTAK LABORATORIES, INC.
QC 4 SMX-OF
In Commercial Distribution

  • B80002942500080 ()
  • B80002942500081 ()
  • B80002942500082 ()
  • B80002942500083 ()
  • B80002942500086 ()
  • B80002942500087 ()
  • B80002942500088 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DRUGS OF ABUSE CALIBRATOR V6 - B80002942500070

No Description
UTAK LABORATORIES, INC.
DOA CAL P OF V6
In Commercial Distribution

  • B80002942500071 ()
  • B80002942500070 ()
  • B80002942500072 ()
  • B80002942500073 ()
  • B80002942500076 ()
  • B80002942500077 ()
  • B80002942500078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC HIGH - B80002942500060

No Description
UTAK LABORATORIES, INC.
P/Z QC H U F ML
In Commercial Distribution

  • B80002942500060 ()
  • B80002942500061 ()
  • B80002942500062 ()
  • B80002942500063 ()
  • B80002942500066 ()
  • B80002942500067 ()
  • B80002942500068 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z QC LOW - B80002942500050

No Description
UTAK LABORATORIES, INC.
P/Z QC LOW
In Commercial Distribution

  • B80002942500051 ()
  • B80002942500050 ()
  • B80002942500052 ()
  • B80002942500053 ()
  • B80002942500056 ()
  • B80002942500057 ()
  • B80002942500058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR V2 - B80002942500040

No Description
UTAK LABORATORIES, INC.
P/Z CAL V2 U F ML
In Commercial Distribution

  • B80002942500041 ()
  • B80002942500040 ()
  • B80002942500042 ()
  • B80002942500043 ()
  • B80002942500046 ()
  • B80002942500047 ()
  • B80002942500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PSYCH URINE V3 CALIBRATOR - B80002942500030

No Description
UTAK LABORATORIES, INC.
PSY UR V3 CAL
In Commercial Distribution

  • B80002942500030 ()
  • B80002942500031 ()
  • B80002942500032 ()
  • B80002942500033 ()
  • B80002942500036 ()
  • B80002942500037 ()
  • B80002942500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

P/Z CALIBRATOR - B80002942500020

No Description
UTAK LABORATORIES, INC.
P/Z CAL U F ML
In Commercial Distribution

  • B80002942500020 ()
  • B80002942500021 ()
  • B80002942500022 ()
  • B80002942500023 ()
  • B80002942500026 ()
  • B80002942500027 ()
  • B80002942500028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PM PANEL COMBO V9 - B80002942500010

No Description
UTAK LABORATORIES, INC.
PM PAN COM V9
In Commercial Distribution

  • B80002942500010 ()
  • B80002942500011 ()
  • B80002942500012 ()
  • B80002942500013 ()
  • B80002942500016 ()
  • B80002942500017 ()
  • B80002942500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

GHB 20 MG/L - B80001978000020

GHB 20 MG/L
UTAK LABORATORIES, INC.
GHB 20 U IN
In Commercial Distribution

  • B80001978000021 ()
  • B80001978000020 ()
  • B80001978000022 ()
  • B80001978000023 ()
  • B80001978000026 ()
  • B80001978000027 ()
  • B80001978000028 ()


  • Gamma-hydroxybutyrate (GHB) IVD, control

BUSULFAN LEVEL 2 - B80001696000080

BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control
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