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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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LYFO DISK™ - 10845357013269

LYFO DISK™ E. coli ATCC 14169™
MICROBIOLOGICS INC.
0543L
In Commercial Distribution

  • 10845357013269 ()
0543L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357013245

KWIK-STIK™ E. coli ATCC 14169™
MICROBIOLOGICS INC.
0543U
In Commercial Distribution

  • 20845357013242 ()
  • 10845357013245 ()
  • 30845357013256 ()
0543U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357013177

LYFO DISK™ B. spizizenii ATCC 19659™
MICROBIOLOGICS INC.
0540L
In Commercial Distribution

  • 10845357013177 ()
0540L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357013153

KWIK-STIK™ B. spizizenii ATCC 19659™
MICROBIOLOGICS INC.
0540U
In Commercial Distribution

  • 30845357013164 ()
  • 10845357013153 ()
  • 20845357013150 ()
0540U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357013146

LYFO DISK™ B. thuringiensis (H3: 3a 3b) ATCC 33679™
MICROBIOLOGICS INC.
0539L
In Commercial Distribution

  • 10845357013146 ()
0539L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357013122

KWIK-STIK™ B. thuringiensis (H3: 3a 3b) ATCC 33679™
MICROBIOLOGICS INC.
0539U
In Commercial Distribution

  • 20845357013129 ()
  • 10845357013122 ()
  • 30845357013133 ()
0539U

  • Multiple bacteria species culture isolate identification control IVD, kit

MEDRAD Imaging Bulk Package Transfer Spike - 00616258022369

ASSY,IBP TRANSFER SPIKE,FINAL (86613735)
Bayer Medical Care Inc.
GBP TS
In Commercial Distribution

  • 40616258022367 ()
  • 00616258022369 ()
GBP TS

  • Fluid transfer set, general-purpose

MEDRAD® Imaging Bulk Package Transfer Set - 00616258008196

ASSEMBLY,FINAL,IBPTS, MC (CT - SWABBABLE VALVE TRANSFER SET, SVTS) (85199579)
BAYER MEDICAL CARE INC.
IBP TS
In Commercial Distribution

  • 40616258008194 ()
  • 00616258008196 ()
IBP TS

  • Fluid transfer set, general-purpose

Mycobacti-Loops - 00848838082757

M. racemosus ATCC 42647 PK/5
REMEL, INC.
R4609440
In Commercial Distribution

  • 00848838082757 ()
R4609440

  • Culture medium control

Mycobacti-Loops - 00848838071690

M. intracellulare ATCC 13950 PK/1
REMEL, INC.
R4610010
In Commercial Distribution

  • 00848838071690 ()
R4610010

  • Culture medium control

REMEL - 00848838051326

PK/5 TCG PROBESWAB QC
REMEL, INC.
R485103
In Commercial Distribution

  • 00848838051326 ()
R485103

  • Culture medium control

REMEL - 00848838051319

PK/5 CGC PROBESWAB QC
REMEL, INC.
R485102
In Commercial Distribution

  • 00848838051319 ()
R485102

  • Culture medium control

Mycobacti-Loops - 00848838042836

P. mirabilis ATCC 12453 CFUrine KT/2 TST
REMEL, INC.
R4702000
In Commercial Distribution

  • 00848838042836 ()
R4702000

  • Culture medium control

Sure-Vue - 00613647000311

Sure-Vue Signature Cryptosporidium and Giardia Control Kit
FISHER SCIENTIFIC COMPANY L.L.C.
23-200-278
In Commercial Distribution

  • 20613647000315 ()
  • 00613647000311 ()
23200278

  • Multiple faecal parasite antigen IVD, control

N/A - 04052536184088

ulrich Transfer Set, 20 in for USA only: For use with Omnipaque Imaging Bulk Package
Ulrich GmbH & Co. KG
XD 40101
In Commercial Distribution

  • 04052536184088 ()
XD 40101

  • Fluid transfer set, general-purpose

MYCOPLASMA CONTROL - 03661540100505

The MYCOPLASMA CONTROL kit contains Ureaplasma urealyticum (U.u) and Mycoplasma hominis (M.h) strains and has been designed for the quality control of liquid media methods of in vitro urogenital mycoplasma diagnosis.
ELITECH MICROBIO
00900
In Commercial Distribution

  • 03661540100505 ()
00900

  • Multiple bacteria species culture isolate identification control IVD, kit

chromID® Strepto B agar - 03573026598075

chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women
BIOMERIEUX SA
chromID® Strepto B agar
In Commercial Distribution

  • 03573026505684 ()
  • 03573026598075 ()
  • 03573026598082 ()


  • Differential/selective agar culture medium IVD

McKesson - 10612479188454

MCK Ultrasnd Gel CLR 5L, ns
MCKESSON MEDICAL-SURGICAL INC.
4964
In Commercial Distribution

  • 10612479188454 ()
  • 40612479188462 ()


  • Skin topical coupling gel

McKesson - 10612479188430

MCK UltrasndGel Clr 8.5oz,ns
MCKESSON MEDICAL-SURGICAL INC.
4963
In Commercial Distribution

  • 10612479188430 ()
  • 40612479188448 ()


  • Skin topical coupling gel

McKesson - 10612479188416

MCK Ultrasnd Gel PINK 5L,ns
MCKESSON MEDICAL-SURGICAL INC.
4962
In Commercial Distribution

  • 10612479188416 ()
  • 40612479188424 ()


  • Skin topical coupling gel
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