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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MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.
Elitechgroup Mdx LLC
M800573
In Commercial Distribution

  • 03661540950056 ()
M800573

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800572
In Commercial Distribution

  • 03661540950049 ()
M800572

  • Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Lonza Walkersville, Inc.
15-1007I
In Commercial Distribution

  • 00840075403180 ()
15-1007I

  • Ex vivo cell culture medium
No Description
DETAX GmbH
03913
In Commercial Distribution

  • EDET039131 ()


  • Earmould impression material
No Description
BISCO INC.
F-6101D
Not in Commercial Distribution

  • D757F6101D1 ()

  • sixe text
F-6101D

  • Dentine bonding agent/set
No Description
BURKHART DENTAL SUPPLY CO., THE
72720802
In Commercial Distribution

  • 00815878022067 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720801
In Commercial Distribution

  • 00815878022050 ()


  • Dental material mixing nozzle
No Description
BURKHART DENTAL SUPPLY CO., THE
72720800
In Commercial Distribution

  • 00815878022043 ()


  • Dental material mixing nozzle
No Description
SEPTODONT, INC
FP-NOVOINC-054
In Commercial Distribution

  • 07540187001061 ()


  • Orthodontic bracket adhesive
Silcone Dental Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
275380
In Commercial Distribution

  • 07540172008105 ()

  • cartridge
  • Total Volume: 380 Milliliter
275380

  • Silicone dental impression material
No Description
BISCO INC.
F-6102D
Not in Commercial Distribution

  • D757F6102D1 ()

  • sixe text
F-6102D

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6101
Not in Commercial Distribution

  • D757F61010 ()

  • sixe text
F-6101

  • Dentine bonding agent/set
No Description
PEARSON DENTAL SUPPLIES, INC.
D440752
In Commercial Distribution

  • D724D4407521 ()


  • Orthodontic bracket adhesive
600ml
PEARSON DENTAL SUPPLIES, INC.
D010426
In Commercial Distribution

  • D724D0104260 ()


  • Polysulfide dental impression material
600ml
PEARSON DENTAL SUPPLIES, INC.
D010400
In Commercial Distribution

  • D724D0104000 ()


  • Polysulfide dental impression material
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310036
In Commercial Distribution

  • 00810000310036 ()


  • Adhesive bandage
This kit is used for extrusion of teeth. This is a chemical cure self mix kit containing 3 Disposable Oval Attachments with Chain and 2 Disposable Pad Attachments with Chain, Excel Regular Self Mix syringe and Assure Bonding Resin.
RELIANCE ORTHODONTIC PRODUCTS INC
DCCCCK
Not in Commercial Distribution

  • D798DCCCCK0 ()
DCCCCK

  • Dentine bonding agent/set
  • Orthodontic aligner auxiliary attachment kit
  • Orthodontic bracket adhesive
Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix Tips 00850391007313
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007320 ()


  • Synthetic bone graft
  • Bone matrix implant, synthetic, non-antimicrobial
50 mL automix cartridge + 30 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing
PULPDENT CORPORATION
SBU50
In Commercial Distribution

  • D701SBU502 ()

  • Total Volume: 50 Milliliter


  • Dental composite resin
25 mL automix cartridge + 20 mix tips -Multi-purpose core and tooth build up resin- dual cure, fluoride releasing
PULPDENT CORPORATION
SBU
In Commercial Distribution

  • D701SBU2 ()

  • Total Volume: 25 Milliliter


  • Dental composite resin
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