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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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DAUCAL1V5FSEMCE
UTAK LABORATORIES, INC.
DAU CAL 1 V5 F SEMCE
In Commercial Distribution

  • B800DAUCAL1V5FSEMCE5 ()
  • B800DAUCAL1V5FSEMCE0 ()

  • Total Volume: 2 Milliliter
DAU CAL 1 V5 F SEMCE

  • Multiple-type clinical chemistry analyte profile IVD, control
DAUCAL1V4F2PTTL
UTAK LABORATORIES, INC.
DAU CAL 1 V4 F 2PT TL
In Commercial Distribution

  • B800DAUCAL1V4F2PTTL5 ()
  • B800DAUCAL1V4F2PTTL0 ()

  • Total Volume: 0.45 Milliliter
DAU CAL 1 V4 F 2PT TL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU CAL 1 V3 F NHI
In Commercial Distribution

  • B800DAUCAL1V3FNHI5 ()
  • B800DAUCAL1V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 1 V3 F NHI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CALIBRATOR 1
UTAK LABORATORIES, INC.
DAU CAL 1 U F NPIL
In Commercial Distribution

  • B800DAUCAL1UFNPIL5 ()
  • B800DAUCAL1UFNPIL0 ()

  • Total Volume: 2 Milliliter
DAU CAL 1 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR 1
UTAK LABORATORIES, INC.
DAU CAL 1 F IUH
In Commercial Distribution

  • B800DAUCAL1FIUH5 ()
  • B800DAUCAL1FIUH0 ()

  • Total Volume: 0.5 Milliliter
DAU CAL 1 F IUH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 F HCMC
In Commercial Distribution

  • B800DAU1FHCMC5 ()
  • B800DAU1FHCMC0 ()

  • Total Volume: 10 Milliliter
DAU 1 F HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 F APS
In Commercial Distribution

  • B800DAU1FAPS5 ()
  • B800DAU1FAPS0 ()

  • Total Volume: 1 Milliliter
DAU 1 F APS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE PLUS LEVEL 1
UTAK LABORATORIES, INC.
DAU + 1 F APC
In Commercial Distribution

  • B800DAU1FAPC5 ()
  • B800DAU1FAPC0 ()

  • Total Volume: 2 Milliliter
DAU + 1 F APC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE QC LEVEL 2
UTAK LABORATORIES, INC.
DA SMX-OF QC 2
In Commercial Distribution

  • B800DASMXOFQC25 ()
  • B800DASMXOFQC20 ()

  • Total Volume: 4 Milliliter
DA SMX-OF QC 2

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE QC LEVEL 1
UTAK LABORATORIES, INC.
DA SMX-OF QC 1
In Commercial Distribution

  • B800DASMXOFQC15 ()
  • B800DASMXOFQC10 ()

  • Total Volume: 4 Milliliter
DA SMX-OF QC 1

  • Multiple therapeutic drugs/drugs of abuse IVD, control
New Easy-to-Use Disk Format. Hardy Diagnostics now offers a convenient way of testing ß-lactamase activity in bacteria. The rapid Nitrocef test consists of a disk that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms: • Neisseria gonorrhoeae • Haemophilus spp. • Moraxella (Branhamella) catarrhalis • Staphylococcus spp. • Enterococcus spp. • Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella) The rapid Nitrocef Disk test can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. These HardyDisks™ are packages loose in a glass vial.
HARDY DIAGNOSTICS
Z7301
In Commercial Distribution

  • 00816576028887 ()
  • 00816576028894 ()
Z7301

  • Beta-lactamase production microbial reagent IVD
Positive and Negative Oral Fluid Controls
BRANAN MEDICAL CORPORATION
OC001
Not in Commercial Distribution

  • 00816555020222 ()
OC001

  • Multiple drugs of abuse IVD, calibrator
Licox® Complete Brain Tunnelling Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IT2
Not in Commercial Distribution

  • M273IT21 ()
  • 10381780041207 ()

  • 130 mm x 35 mm x 313 mm
IT2

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP2P
Not in Commercial Distribution

  • M273IP2P1 ()
  • 10381780041191 ()

  • 130 mm x 35 mm x 313 mm
IP2P

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP1P
Not in Commercial Distribution

  • M273IP1P1 ()
  • 10381780041184 ()

  • 130 mm x 35 mm x 313 mm
IP1P

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM3ST
Not in Commercial Distribution

  • M273IM3ST1 ()
  • 10381780041177 ()

  • 130 mm x 50 mm x 313 mm
IM3ST

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM3S
Not in Commercial Distribution

  • M273IM3S1 ()
  • 10381780041160 ()

  • 130 mm x 35 mm x 313 mm
IM3S

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM2S
Not in Commercial Distribution

  • M273IM2S1 ()
  • 10381780041153 ()

  • 130 mm x 35 mm x 313 mm
IM2S

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM1S
Not in Commercial Distribution

  • M273IM1S1 ()
  • 10381780041146 ()

  • 130 mm x 35 mm x 313 mm
IM1S

  • Intracerebral sensor catheter, short-term
Licox® Combined Oxygen and Temperature Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1P1
Not in Commercial Distribution

  • M273CC1P11 ()
  • 10381780041078 ()

  • 130 mm x 35 mm x 313 mm
CC1P1

  • Intracerebral sensor catheter, short-term
Licox® Oxygen Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1SB
Not in Commercial Distribution

  • M273CC1SB1 ()
  • 10381780041061 ()

  • 130 mm x 35 mm x 313 mm
CC1SB

  • Intracerebral sensor catheter, short-term
CHANG Medium D with L-Glutamine. 500mL bottle.
IRVINE SCIENTIFIC, LLC
T105-500ML
In Commercial Distribution

  • 00810195240637 ()
T105

  • Cell culture medium IVD
CHANG Medium D with L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
T105-100ML
In Commercial Distribution

  • 00810195240620 ()
T105

  • Cell culture medium IVD
CHANG Medium C Frozen Supplement (14mL)
IRVINE SCIENTIFIC, LLC
C106-14ML
In Commercial Distribution

  • 00810195240613 ()
C106

  • Cell culture medium IVD
CHANG Amnio with Gentamicin and L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99473-100ML
In Commercial Distribution

  • 00810195240590 ()
99473

  • Cell culture medium IVD
CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99404-100ML
In Commercial Distribution

  • 00810195240583 ()
99404

  • Cell culture medium IVD
Bone Marrow Culture Medium with Gentamicin. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91031-500ML
In Commercial Distribution

  • 00810195240576 ()
91031

  • Cell culture medium IVD
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.
STRECK, INC.
218752
In Commercial Distribution

  • 50844509000612 ()

  • Total Volume: 2.5 Milliliter
218752

  • Full blood count IVD, control
RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software
25SH 14X36IN E BLUE X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976046050 ()
  • 00889976046058 ()
6046056

  • Medical x-ray film, screen
25SH 14X36IN E GREEN X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045978 ()
  • 00889976045976 ()
6045975

  • Medical x-ray film, screen
10SC 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971933980 ()
  • 00088997193398 ()
1933985

  • Digital imaging cassette/phosphor plate
25SH 14X36IN (FLAT) BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976041383 ()
  • 00889976041381 ()
6041388

  • Medical x-ray film, screen
25SH 14X36IN (FLAT) GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
Not in Commercial Distribution

  • 60889976041376 ()
  • 00889976041374 ()
6041370

  • Medical x-ray film, screen
10SC 18X24CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971157539 ()
  • 00088997115753 ()
1157536

  • Digital imaging cassette/phosphor plate
100SH 35X35-14X14 E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976046593 ()
  • 40889976046599 ()
  • 00889976046591 ()
6046593

  • Medical x-ray film, screen
100SH 8X10IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046272 ()
  • 40889976046278 ()
  • 00889976046270 ()
6046270

  • Medical x-ray film, non-screen
100SH 11X14IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046265 ()
  • 40889976046261 ()
  • 00889976046263 ()
6046262

  • Medical x-ray film, non-screen
100SH 5X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046258 ()
  • 40889976046254 ()
  • 00889976046256 ()
6046254

  • Medical x-ray film, non-screen
100SH 15X30-6X12 DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046241 ()
  • 40889976046247 ()
  • 00889976046249 ()
6046247

  • Medical x-ray film, non-screen
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