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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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ID NOW Influenza A & B 2 Control Swab Kit - 10811877011221

Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control

Alere™ i Influenza A & B Control Swab Kit - 10811877010811

Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control

ID NOW Influenza A & B Control Swab Kit - 10811877010439

Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control

Fluoro-CheckTM Influenza A+B - 00895160002526

An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

ORTHO - 10758750005338

ORTHO® HBc ELISA Test System
ORTHO-CLINICAL DIAGNOSTICS, INC.
933275
In Commercial Distribution

  • 10758750005338 ()
933275

  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

ORTHO - 10758750005321

ORTHO® HBc ELISA Test System
ORTHO-CLINICAL DIAGNOSTICS, INC.
933245
In Commercial Distribution

  • 10758750005321 ()
933245

  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

LIAISON XL MUREX Control HBcIgM - 08056771103398

No Description
DIASORIN SPA
318141
In Commercial Distribution

  • 28056771103392 ()
  • 08056771103398 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ETI-AB-COREK PLUS - 08056771102322

No Description
DIASORIN SPA
P001927
In Commercial Distribution

  • 08056771102322 ()


  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

RAMP® Flu A + B TEST KIT; 25 TESTS - 10627966005176

No Description
Response Biomedical Corp
C1107
Not in Commercial Distribution

  • 10627966005176 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

ACCURUN® - 00816784021007

No Description
Lgc Clinical Diagnostics, Inc.
2000-0071
In Commercial Distribution

  • 00816784021007 ()


  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020345

ACCURUN 125 Anti-HBs 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0077
In Commercial Distribution

  • 00816784020345 ()
2015-0077

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020314

ACCURUN 120 HAV IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0073
In Commercial Distribution

  • 00816784020314 ()
2015-0073

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020284

ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0070
In Commercial Distribution

  • 00816784020284 ()
2015-0070

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control

ACCURUN® - 00816784020277

ACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0068
In Commercial Distribution

  • 00816784020277 ()
2015-0068

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ACCURUN® - 00816784020208

ACCURUN 52 Multi-Marker Hepatitis 2 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0043
In Commercial Distribution

  • 00816784020208 ()
2000-0043

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020192

ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0041
In Commercial Distribution

  • 00816784020192 ()
2000-0041

  • Hepatitis B virus antigen/antibody marker IVD, control

ACCURUN® - 00816784020185

ACCURUN 51 Multi-Marker Hepatitis 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0040
In Commercial Distribution

  • 00816784020185 ()
2000-0040

  • Hepatitis B virus antigen/antibody marker IVD, control

IMAGEN Influenza Virus A and B - 05032384502981

No Description
OXOID LIMITED
K610511-2
In Commercial Distribution

  • 05032384502981 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

NA - 05032384005895

No Description
OXOID LIMITED
CT0044B
In Commercial Distribution

  • 05032384005895 ()
  • 05032384501946 ()


  • Polymixin B susceptibility testing disc IVD

VIROTROL - 00847661002840

VIROTROL HBc-IgM (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00143
In Commercial Distribution

  • 00847661002840 ()
00143

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

Alinity - 00380740167455

Alinity s Anti-HBc Calibrator Kit
Abbott GmbH
06P0603
In Commercial Distribution

  • 00380740167455 ()
06P0603

  • Hepatitis B virus core total antibody IVD, calibrator

NATtrol™ - 01220000260085

The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Influenza A/B Positive Control
In Commercial Distribution

  • 01220000260085 ()
NATFLUAB-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control

NATtrol™ - 01220000260078

The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza/RSV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Influenza/RSV Negative Control
In Commercial Distribution

  • 01220000260078 ()
NATCXVA9-6C-IVD

  • Influenza A/B virus nucleic acid IVD, control

Solana - 30014613336990

Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control

D3 Fastpoint - 30014613330851

L-DFA Influenza A/Influenza B Reagent
DIAGNOSTIC HYBRIDS, INC.
01-123104
In Commercial Distribution

  • 30014613330851 ()
01-123104

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330325

De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Quidel Molecular - 30014613311065

QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control

Sofia - 30014613202547

Sofia Flu A+B 25T
QUIDEL CORPORATION
20254
In Commercial Distribution

  • 30014613202547 ()
20254

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Sofia - 30014613202189

Sofia Flu A+B 25T
QUIDEL CORPORATION
20218
In Commercial Distribution

  • 30014613202189 ()
20218

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System - 00875197005950

No Description
Roche Molecular Systems, Inc.
08160104190
In Commercial Distribution

  • 00875197005950 ()
08160104190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System - 00875197005653

No Description
Roche Molecular Systems, Inc.
07402686190
In Commercial Distribution

  • 00875197005653 ()
07402686190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System - 00875197005608

No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

JBAIDS - 00851458005068

JBAIDS IVD Influenza A & B Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0137
Not in Commercial Distribution

  • 00851458005068 ()
JRPD-ASY-0137

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Alere™ i Influenza A & B - 10811877010804

A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
425-024
Not in Commercial Distribution

  • 10811877010804 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

ID NOW Influenza A & B 2 - 10811877010422

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Alere i Influenza A & B 2 - 10811877010019

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
Not in Commercial Distribution

  • 10811877010019 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

LIAISON XL MUREX HBsAg Confirmatory - 08056771103589

No Description
DIASORIN S.P.A.
318110
In Commercial Distribution

  • 28056771103583 ()
  • 08056771103589 ()


  • Hepatitis B virus surface antigen IVD, reagent

LIAISON XL MUREX HBcIgM - 08056771103381

No Description
DIASORIN SPA
318140
In Commercial Distribution

  • 08056771103381 ()
  • 18056771103388 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ETI-CORE-IGMK PLUS - 08056771102339

No Description
DIASORIN SPA
P001928
In Commercial Distribution

  • 08056771102339 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Coxsackie B1-B6 Negative Control - B110CBN33100

No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

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