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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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
The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes.
Elitechgroup Mdx LLC
M800689
In Commercial Distribution

  • 03661540951756 ()
M800689

  • Nucleic acid amplification mastermix kit IVD
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution

  • D801ID6602I1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02 S
In Commercial Distribution

  • D801SP6602S1 ()
66-02

  • Dentine adhesive
No Description
Dentsply International Inc.
644432
In Commercial Distribution

  • D0016444321 ()
644432

  • Solution agitator
  • Root canal ultrasonic irrigation handpiece tip
  • Medical equipment/instrument drape, single-use
No Description
Dentsply International Inc.
644431
In Commercial Distribution

  • D0016444311 ()
644431

  • Medical equipment/instrument drape, single-use
  • Root canal ultrasonic irrigation handpiece tip
  • Solution agitator
No Description
Lonza Verviers
BESP698P20S
In Commercial Distribution

  • 05407010126983 ()
BESP698P20S

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X10
Not in Commercial Distribution

  • 05407010124507 ()
BESP808X10

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X5
In Commercial Distribution

  • 05407010121612 ()
BESP808X5

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808X0.365
In Commercial Distribution

  • 05407010121605 ()
BESP808X0.365

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808J
In Commercial Distribution

  • 05407010121599 ()
BESP808J

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808D
In Commercial Distribution

  • 05407010121582 ()
BESP808D

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B1
In Commercial Distribution

  • 05407010121575 ()
BESP808B1

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B0.5
In Commercial Distribution

  • 05407010121568 ()
BESP808B0.5

  • Ex vivo cell culture medium
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-2005 P
Not in Commercial Distribution

  • 04049016053255 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1010 P
Not in Commercial Distribution

  • 04049016053248 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1005 P
Not in Commercial Distribution

  • 04049016053231 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 215b-1003 P
Not in Commercial Distribution

  • 04049016053224 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800726
In Commercial Distribution

  • 03661540952746 ()


  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ Candida auris Probe Mix ASR is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 of Candida auris.
Elitechgroup Mdx LLC
800730
In Commercial Distribution

  • 03661540952548 ()
800730

  • Assay development analyte-specific reagent IVD
DSQ Alert™ Candida auris Primer Mix ASR is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify an 125 bp region within the ITS2 gene of Candida auris. The mix consists of a single vial containing a set of primers in a 1X TE buffer solution.
Elitechgroup Mdx LLC
800729
In Commercial Distribution

  • 03661540952531 ()
800729

  • Assay development analyte-specific reagent IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800810
In Commercial Distribution

  • 03661540952524 ()
M800810

  • Nucleic acid amplification mastermix kit IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800809
In Commercial Distribution

  • 03661540952517 ()
M800809

  • Nucleic acid amplification mastermix kit IVD
MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800498-am
In Commercial Distribution

  • 03661540950179 ()
800498-am

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus. The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all known Adenovirus types.
Elitechgroup Mdx LLC
800497-am
In Commercial Distribution

  • 03661540950162 ()
800497-am

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800424-am
In Commercial Distribution

  • 03661540950148 ()
800424-am

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from the p140 region of the BNRF1 gene of EBV.
Elitechgroup Mdx LLC
800414-am
In Commercial Distribution

  • 03661540950131 ()
800414-am

  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800588-am
In Commercial Distribution

  • 03661540950094 ()
M800588-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
M800587-am
In Commercial Distribution

  • 03661540950087 ()
M800587-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. The probe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800586-am
In Commercial Distribution

  • 03661540950070 ()
M800586-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
M800585-am
In Commercial Distribution

  • 03661540950063 ()
M800585-am

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleic acid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
800498
In Commercial Distribution

  • 03661540951671 ()
800498

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800421
In Commercial Distribution

  • 03661540951534 ()
800421

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800333
In Commercial Distribution

  • 03661540951282 ()
800333

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012381
In Commercial Distribution

  • 00359883006525 ()

  • Total Volume: 380 Milliliter
012381

  • Silicone dental impression material
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012386
In Commercial Distribution

  • 00359883005986 ()

  • Total Volume: 380 Milliliter
012386

  • Silicone dental impression material
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Glass Ionomer Cement For Orthodontic Bands-Natural Color
ORTHO SPECIALTIES
600-401
In Commercial Distribution

  • 00842452100590 ()
600-401

  • Orthodontic bracket adhesive
Glass Ionomer Cement For Orthodontic Bands-Blue Color
ORTHO SPECIALTIES
600-400
In Commercial Distribution

  • 00842452100583 ()
600-400

  • Orthodontic bracket adhesive
No Description
BISCO INC.
F-6103
Not in Commercial Distribution

  • D757F61030 ()

  • sixe text
F-6103

  • Dentine bonding agent/set
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.396
In Commercial Distribution

  • 04038917926713 ()
  • 04038917926690 ()
72.694.396

  • Assay container IVD, single-use
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012385
In Commercial Distribution

  • 07540172000048 ()

  • Total Volume: 380 Milliliter
  • cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012380
In Commercial Distribution

  • 07540172000031 ()

  • Total Volume: 380 Milliliter
  • cartridge
012380

  • Silicone dental impression material
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