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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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KIT, OPTIGEN US Food 30 (100ND)
Minaris Medical America, Inc.
85267
In Commercial Distribution

  • 00813382010020 ()
85267

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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
SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S274
In Commercial Distribution

  • 00810000529551 ()
S274

  • Dental composite resin
SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S273
In Commercial Distribution

  • 00810000529544 ()
S273

  • Dental composite resin
SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S272
In Commercial Distribution

  • 00810000529537 ()
S272

  • Dental composite resin
SEcure® Self-Etch Primer 3ml
PARKELL, INC.
S271
In Commercial Distribution

  • 00810000529520 ()
S271

  • Dental composite resin
SEcure® Resin Cement System Kit with Translucent Shade
PARKELL, INC.
S270
In Commercial Distribution

  • 00810000529513 ()
S270

  • Dental composite resin
BEAUTIFIL KIDS SA B1 1.0g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10150 ()
Y1015

  • Dental composite resin
BEAUTIFIL KIDS SA A2 1.0g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10140 ()
Y1014

  • Dental composite resin
BEAUTIFIL KIDS SA A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10110 ()
Y1011

  • Dental composite resin
BEAUTIFIL KIDS SA B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10120 ()
Y1012

  • Dental composite resin
LINEARITY KIT 313-50 HEPLINE
MEDTRONIC, INC.
313-50
In Commercial Distribution

  • 00763000014902 ()


  • Coagulation timer IVD
DAU 2 V3 UCSD
UTAK LABORATORIES, INC.
DAU LEVEL 2 V3
In Commercial Distribution

  • B800DAU2V3UCSD5 ()
  • B800DAU2V3UCSD0 ()

  • Total Volume: 1.5 Milliliter
DAU LEVEL 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LEVEL 1 V3
UTAK LABORATORIES, INC.
DAU 1 V3 UCSD
In Commercial Distribution

  • B800DAU1V3UCSD5 ()
  • B800DAU1V3UCSD0 ()

  • Total Volume: 1.5 Milliliter
DAU 1 V3 UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control
TRICYCLICS LEVEL 2 V2
UTAK LABORATORIES, INC.
TCA L2 V2 S MAYO
In Commercial Distribution

  • B800TCAL2V2SMAYO5 ()
  • B800TCAL2V2SMAYO0 ()

  • Total Volume: 1 Milliliter
TCA L2 V2 S MAYO

  • Multiple antidepressant therapeutic drug monitoring IVD, control
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-053
In Commercial Distribution

  • 00884999042773 ()
06N38-053

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-033
In Commercial Distribution

  • 00884999042728 ()
06N38-033

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-91
In Commercial Distribution

  • 00884999038462 ()
2N40-91

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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