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Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges - 04987270231432

No Description
FUJIREBIO INC.
231432
In Commercial Distribution

  • 04987270231432 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

N Latex ADNase B (USA) - 00630414285054

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

CD39 [EPR20627] - 00847627030580

No Description
BIOCARE MEDICAL LLC
AVI3283G
In Commercial Distribution

  • 00847627030580 ()


  • Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007122

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007122 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007115

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007115 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007092

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 4
In Commercial Distribution

  • 00859882007092 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007085

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 3
In Commercial Distribution

  • 00859882007085 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007351

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrators Kit
In Commercial Distribution

  • 00859882007351 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007337

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Calibrators Kit
In Commercial Distribution

  • 00859882007337 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007313

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HBV Discriminatory Probe Reagent Kit
In Commercial Distribution

  • 00859882007313 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007306

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HCV Discriminatory Probe Reagent Kit
In Commercial Distribution

  • 00859882007306 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007290

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1 Discriminatory Probe Reagent Kit
In Commercial Distribution

  • 00859882007290 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007283

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 4
In Commercial Distribution

  • 00859882007283 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007276

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007276 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007269

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007269 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007252

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 1
In Commercial Distribution

  • 00859882007252 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007245

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 3
In Commercial Distribution

  • 00859882007245 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007238

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 2
In Commercial Distribution

  • 00859882007238 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007221

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 1
In Commercial Distribution

  • 00859882007221 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007214

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Control Kit
In Commercial Distribution

  • 00859882007214 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007207

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrator Kit
In Commercial Distribution

  • 00859882007207 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007191

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Calibrators Kit
In Commercial Distribution

  • 00859882007191 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007184

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Controls Kit
In Commercial Distribution

  • 00859882007184 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007177

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HBV dprobe kit
In Commercial Distribution

  • 00859882007177 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007160

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HCV dprobe kit
In Commercial Distribution

  • 00859882007160 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007153

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1 dprobe kit
In Commercial Distribution

  • 00859882007153 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007146

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 5
In Commercial Distribution

  • 00859882007146 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007139

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 4
In Commercial Distribution

  • 00859882007139 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007108

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 1
In Commercial Distribution

  • 00859882007108 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007078

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 2
In Commercial Distribution

  • 00859882007078 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007061

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 1
In Commercial Distribution

  • 00859882007061 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007344

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Controls Kit
In Commercial Distribution

  • 00859882007344 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Assay - 00859882007320

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Controls Kit
In Commercial Distribution

  • 00859882007320 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® MPX (480 tests) - 00875197004779

No Description
Roche Diagnostics GmbH
06998917190
In Commercial Distribution

  • 00875197004779 ()
06998917190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® TaqScreen MPX Test, v2.0 - 00875197004045

No Description
Roche Molecular Systems, Inc.
2.0
In Commercial Distribution

  • 00875197004045 ()
05969484190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® AmpliScreen HBV Test - 00875197002102

No Description
Roche Molecular Systems, Inc.
03599779190
In Commercial Distribution

  • 00875197002102 ()
03599779190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® TaqScreen MPX Test - 00875197001662

No Description
Roche Molecular Systems, Inc.
04584252190
In Commercial Distribution

  • 00875197001662 ()
04584252190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® AmpliScreen HIV-1 Test, v1.5 - 00875197001099

No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197001099 ()
03322114018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® AmpliScreen HCV Test, v2.0 - 00875197001068

No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197001068 ()
03302563018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

N Latex ADNase B - 00842768013317

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110CB33120

No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System - B110CB33060

No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Elecsys Beta-Amyloid (1-42) CSF II - 07613336208359

No Description
Roche Diagnostics GmbH
08821909160
In Commercial Distribution

  • 07613336208359 ()
08821909160

  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Elecsys beta-Amyloid (1-42) CSF II - 07613336166321

No Description
Roche Diagnostics GmbH
08821941190
In Commercial Distribution

  • 07613336166321 ()
08821941190

  • Amyloid B component IVD, kit, chemiluminescent immunoassay

cobas® MPX (96 tests) - 20875197004766

No Description
Roche Diagnostics GmbH
06998909190
In Commercial Distribution

  • 20875197004766 ()
06998909190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500723

No Description
Hologic, Inc.
Auto Detect Reagents
Not in Commercial Distribution

  • 15420045500723 ()
301120

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500716

No Description
Hologic, Inc.
Assay Fluids
Not in Commercial Distribution

  • 15420045500716 ()
301116

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500709

No Description
Hologic, Inc.
Procleix System Fluid Preservative
Not in Commercial Distribution

  • 15420045500709 ()
301175

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500693

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Procleix Buffer for Deactivation Fluid
Not in Commercial Distribution

  • 15420045500693 ()
303666

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix - 15420045500686

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Procleix Wash Solution
Not in Commercial Distribution

  • 15420045500686 ()
303665

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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