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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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MGB Alert HSV-1 Probe Mix ASR, 09N44-002 - 03661540950070

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-1 Primer Mix ASR, 09N44-003 - 03661540950063

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 Pneumocystis Probe Mix 48rxn, - 03661540950049

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)

Macroduct® Advanced Supply Kit, Qty 6 - 03661540304378

For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-268
In Commercial Distribution

  • 03661540304378 ()


  • Sweat-induction iontophoresis system

Macroduct® Supply Kit, w/o Dye, Qty 6 - 03661540302169

For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-032-ND
In Commercial Distribution

  • 03661540302169 ()


  • Sweat-induction iontophoresis system

Macroduct® Supply Kit, Qty 6 - 03661540302152

For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-032
In Commercial Distribution

  • 03661540302152 ()


  • Sweat-induction iontophoresis system

Macroduct® Pilogel Discs - 03661540302084

For use with Macroduct® Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
SS-023
In Commercial Distribution

  • 03661540302084 ()


  • Sweat-induction iontophoresis system

SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE - D77819960101

Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-6010
In Commercial Distribution

  • D77819960101 ()

  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
199-6010

  • Dental composite resin

AQC - 08600105181752

Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
Not in Commercial Distribution

  • 08600105181752 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002217

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-20X5mL
In Commercial Distribution

  • 00893727002217 ()
  • 10893727002214 ()

  • Total Volume: 5 Milliliter
90128

  • IVF medium

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002200

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium

CLOTtrac® - 10885074184927

CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
MEDTRONIC, INC.
550-10
In Commercial Distribution

  • 10885074184927 ()
  • 00885074184920 ()


  • Multiple coagulation factor IVD, control

CLOTtrac® - 10885074184910

CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-09
In Commercial Distribution

  • 10885074184910 ()
  • 00885074184913 ()


  • Multiple coagulation factor IVD, control

CLOTtrac® - 10885074184880

CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-08
In Commercial Distribution

  • 10885074184880 ()
  • 00885074184883 ()


  • Multiple coagulation factor IVD, control

CLOTtrac® - 10885074184873

CONTROL 550-07 CLOTTRAC HR 11L 15BX
MEDTRONIC, INC.
550-07
In Commercial Distribution

  • 10885074184873 ()
  • 00885074184876 ()


  • Multiple coagulation factor IVD, control

CLOTtrac® - 10885074184828

CONTROL 550-01 CLOTTRAC CWB 11L 15BX
MEDTRONIC, INC.
550-01
In Commercial Distribution

  • 10885074184828 ()
  • 00885074184821 ()


  • Multiple coagulation factor IVD, control

CD-Chex Plus - 10844509000096

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
STRECK, INC.
213330
In Commercial Distribution

  • 10844509000096 ()

  • Total Volume: 2.5 Milliliter
213330

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 10844509000089

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213325
In Commercial Distribution

  • 10844509000089 ()

  • Total Volume: 2.5 Milliliter
213325

  • Multiple CD cell marker IVD, control

Access AFP - H628332111

The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay

uTASWako AFP-L3 Sample Dilution Buffer - 10856626006189

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
Not in Commercial Distribution

  • 10856626006189 ()
  • 00856626006182 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay

uTASWako AFP-L3 Control L - 10856626006172

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
Not in Commercial Distribution

  • 10856626006172 ()
  • 00856626006175 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control

uTASWako DCP Control L - 10856626006134

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
Not in Commercial Distribution

  • 10856626006134 ()
  • 00856626006137 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

uTASWako AFP-L3 Control H - 10856626006073

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
Not in Commercial Distribution

  • 10856626006073 ()
  • 00856626006076 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control

uTASWako DCP Control H - 10856626006066

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
Not in Commercial Distribution

  • 10856626006066 ()
  • 00856626006069 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

HDL-C/LDL-C Calibrator - 10856626006035

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
990-28011
Not in Commercial Distribution

  • 10856626006035 ()
  • 00856626006038 ()
990-28011

  • High density lipoprotein (HDL) cholesterol IVD, calibrator

Multi Calibrator Lipids - 10856626006028

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
Not in Commercial Distribution

  • 10856626006028 ()
  • 00856626006021 ()
464-01601

  • Triglyceride IVD, calibrator

NEFA Standard Solution - 10856626006011

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
Not in Commercial Distribution

  • 10856626006011 ()
  • 00856626006014 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator

Measles Virus Primer Pair - 10816101027313

No Description
DIASORIN MOLECULAR LLC
MOL9207
In Commercial Distribution

  • 10816101027313 ()
MOL9207

  • Assay development analyte-specific reagent IVD

Borrelia miyamotoi Primer Pair - 10816101027306

No Description
DIASORIN MOLECULAR LLC
MOL9203
In Commercial Distribution

  • 10816101027306 ()
MOL9203

  • Assay development analyte-specific reagent IVD

Human GAPDH Endogenous Primer Pair - 10816101027290

No Description
DIASORIN MOLECULAR LLC
MOL9178
In Commercial Distribution

  • 10816101027290 ()
MOL9178

  • Assay development analyte-specific reagent IVD

Monkeypox Primer Pair - 10816101027283

No Description
DIASORIN MOLECULAR LLC
MOL9202
In Commercial Distribution

  • 10816101027283 ()
MOL9202

  • Assay development analyte-specific reagent IVD

Prothrombin (FII) HyBeacon Gen II Primer Pair - 10816101027221

No Description
DIASORIN MOLECULAR LLC
MOL9773
In Commercial Distribution

  • 10816101027221 ()
MOL9773

  • Assay development analyte-specific reagent IVD

Factor V HyBeacon II Primer Pair - 10816101027207

No Description
DIASORIN MOLECULAR LLC
MOL9771
In Commercial Distribution

  • 10816101027207 ()
MOL9771

  • Assay development analyte-specific reagent IVD

PS System - Chlor-Xtra Plus Bag (100mL) - 10818207024418

No Description
Vista Dental
803801-16
In Commercial Distribution

  • 10818207024418 ()


  • Root canal cleaning solution

PS System - Chlor-Xtra Plus Bag (60mL) - 10818207024401

No Description
Vista Dental
803802-16
In Commercial Distribution

  • 10818207024401 ()


  • Root canal cleaning solution

PS System - Molar Kit - 10818207024388

No Description
Vista Dental
6000000
In Commercial Distribution

  • 10818207024388 ()


  • Endodontic lavage system

PS System - Premolar Kit - 10818207024371

No Description
Vista Dental
6000001
In Commercial Distribution

  • 10818207024371 ()


  • Endodontic lavage system

PS System - Anterior Kit - 10818207024364

No Description
Vista Dental
6000002
In Commercial Distribution

  • 10818207024364 ()


  • Endodontic lavage system

PS System - Chlor-Xtra Plus Bag (40mL) - 10818207024357

No Description
Vista Dental
803803-16
In Commercial Distribution

  • 10818207024357 ()


  • Root canal cleaning solution

Cyclosporine Calibrator 0 ng/mL - 04015630915644

No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Cyclosporine Calibrators - 04015630915637

No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Licox® - 10381780250340

Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit
Integra LifeSciences Switzerland Sàrl
IT2
In Commercial Distribution

  • M272IT21 ()
  • 10381780250340 ()
  • 10381780041207 ()
IT2

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250333

Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP2P
In Commercial Distribution

  • M272IP2P1 ()
  • 10381780250333 ()
  • 10381780041191 ()
IP2P

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250319

Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP1P
In Commercial Distribution

  • M272IP1P1 ()
  • 10381780250319 ()
  • 10381780041184 ()
IP1P

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250289

Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM3ST
In Commercial Distribution

  • M272IM3ST1 ()
  • 10381780250289 ()
  • 10381780041177 ()
IM3ST

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250210

Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM1S
In Commercial Distribution

  • M272IM1S1 ()
  • 10381780250210 ()
  • 10381780041146 ()
IM1S

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250180

Licox® Brain Tissue Oxygen Monitoring- Oxygen Probe
Integra LifeSciences Switzerland Sàrl
CC1SB
In Commercial Distribution

  • M272CC1SB1 ()
  • 10381780250180 ()
  • 10381780041061 ()
CC1SB

  • Intracerebral sensor catheter, short-term

Licox® - 10381780250173

Licox® Brain Tissue Oxygen Monitoring- Combined Oxygen and Temperature Probe
Integra LifeSciences Switzerland Sàrl
CC1P1
In Commercial Distribution

  • M272CC1P11 ()
  • 10381780250173 ()
  • 10381780041078 ()
CC1P1

  • Intracerebral sensor catheter, short-term

Licox® - 10381780041207

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® - 10381780041191

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
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