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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 Strep A Control Swab Kit - 10811877010866

Control Swabs intended for use only with the Alere i Strep A product.
Alere Scarborough, Inc.
733-080
Not in Commercial Distribution

  • 10811877010866 ()


  • Beta-haemolytic Group A Streptococcus 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 Strep A 2 Control Swab Kit - 10811877010583

Control Swabs intended for use only with the ID NOW Strep A 2 product.
Alere Scarborough, Inc.
734-080
In Commercial Distribution

  • 10811877010583 ()


  • Beta-haemolytic Group A Streptococcus 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

Alere i Strep A 2 Control Swab Kit - 10811877010200

Control Swabs intended for use only with the Alere i Strep A 2 product.
Alere Scarborough, Inc.
734-080
Not in Commercial Distribution

  • 10811877010200 ()


  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent - 10888234002239

Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique. Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.
IMMUCOR, INC.
10 mL size vial / 5mL fill volume
In Commercial Distribution

  • 10888234002239 ()
0066430

  • Anti-Fy^a red blood cell grouping IVD, antibody

Anti-Fya (Monoclonal) Gamma-clone - 10888234002222

This monoclonal reagent is used for the detection of the Fya antigen (of the Duffy blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004816
In Commercial Distribution

  • 10888234002222 ()
0004816

  • Anti-Fy^a red blood cell grouping IVD, antibody

Anti-Jka (Monoclonal) Gamma-clone - 10888234002185

This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004812
In Commercial Distribution

  • 10888234002185 ()
0004812

  • Anti-Jk^a red blood cell grouping IVD, antibody

Anti-Lea (Murine Monoclonal) Gamma-clone - 10888234001881

This reagent is used for the detection of the Lea antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004861
In Commercial Distribution

  • 10888234001881 ()
0004861

  • Anti-Le^a red blood cell grouping IVD, antibody

Anti-Dia - 10888234000839

This reagent is used for the detection of the Di(a) antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007620
In Commercial Distribution

  • 10888234000839 ()
0007620

  • Anti-Di^a red blood cell grouping IVD, antibody

Anti-Jka - 10888234000815

This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007601
In Commercial Distribution

  • 10888234000815 ()
0007601

  • Anti-Jk^a red blood cell grouping IVD, antibody

Anti-Fya - 10888234000792

This reagent is used for the detection of the Fya antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007591
In Commercial Distribution

  • 10888234000792 ()
0007591

  • Anti-Fy^a red blood cell grouping IVD, antibody

Anti-Kpa - 10888234000778

This reagent is used for the detection of the Kpa antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007540
In Commercial Distribution

  • 10888234000778 ()
0007540

  • Anti-Kp^a red blood cell grouping IVD, antibody

ARCHITECT - 00380740001322

ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
ABBOTT LABORATORIES
1L75-55
In Commercial Distribution

  • 00380740001322 ()
01L7555

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

ARCHITECT - 00380740001308

ARCHITECT Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSA Calibrator - 00842768005213

Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Syva® Emit® Cyclosporine Pretreatment Reagent - 00842768001482

Syva® Emit® Cyclosporine Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10445378
In Commercial Distribution

  • 00842768001482 ()
  • 00630414010533 ()
6R719UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator - 00842768001475

Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

Syva® Emit® 2000 Cyclosporine Specific Calibrators - 00842768001468

Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension Vista® System DRUG 3 CAL - 00842768025211

Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSAE Calibrator - 00842768018213

Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension Vista® CSAE CAL - 00842768016448

Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

QC Sets and Panels: Helix Elite™ - 70845357041493

QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
MICROBIOLOGICS INC.
8219
In Commercial Distribution

  • 70845357041493 ()
8219

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Seraclone® Anti-Lea (LE1) - 07611969951970

Blood Grouping Reagent Anti-Lea (LE1); Seraclone® Murine Monoclonal (LEA2); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808403100
In Commercial Distribution

  • 07611969951970 ()
808403100

  • Anti-Le^a red blood cell grouping IVD, antibody

Seraclone® Anti-Fya (JK1) - 07611969951833

Blood Grouping Reagent Anti-Fya (FY1); Seraclone® Human Monoclonal (DG-FYA-02); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808188100
In Commercial Distribution

  • 07611969951833 ()
808188100

  • Anti-Fy^a red blood cell grouping IVD, antibody

Seraclone® Anti-Jka (JK1) - 07611969951758

Blood Grouping Reagent Anti-Jka (JK1); Seraclone® Human Monoclonal (MS15); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808179100
In Commercial Distribution

  • 07611969951758 ()
808179100

  • Anti-Jk^a red blood cell grouping IVD, antibody

Mercodia Lp(a) ELISA - 07350108630016

Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma.
Mercodia AB
10-1106-01
In Commercial Distribution

  • 07350108630016 ()
10-1106-01

  • Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)

ORTHOTM Sera Anti-Lea Blood Grouping Reagent - 10758750013104

The Anti-Lea reagent (Anti-LE1) is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904557
In Commercial Distribution

  • 10758750013104 ()


  • Anti-Le^a red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Jka - 10758750013029

The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904548
In Commercial Distribution

  • 10758750013029 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-Fya - 10758750013005

The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904546
In Commercial Distribution

  • 10758750013005 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody

BIOCLONE - 10758750004140

Anti-Jka (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721380
In Commercial Distribution

  • 10758750004140 ()
721380

  • Anti-Jk^a red blood cell grouping IVD, antibody

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

CEDIA Cyclosporine PLUS High Range Calibrators (450/2000) - 00884883001299

No Description
Microgenics Corporation
100012
In Commercial Distribution

  • 00884883001299 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Anti-Lea (LE1) - 23661562105414

Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
DIAGAST
210541
In Commercial Distribution

  • 23661562105414 ()
210541

  • Anti-Le^a red blood cell grouping IVD, antibody

Anti-Jka (JK1) - 23661562105346

Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

  • Anti-Jk^a red blood cell grouping IVD, antibody

Anti-Fya (FY1) - 23661562105315

Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
DIAGAST
210531
In Commercial Distribution

  • 23661562105315 ()
210531

  • Anti-Fy^a red blood cell grouping IVD, antibody

Simplexa™ Group A Strep Positive Control Pack - 20816101025576

No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

STRADIS HEALTHCARE - M752ZZ07000

HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control

Panther Fusion® - 15420045511590

Group A Strep (GAS) Primers ASR.
Hologic, Inc.
DNA GAS PRIMERS (ASR)
In Commercial Distribution

  • 15420045511590 ()
PRD-05050

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Panther Fusion® - 15420045511576

Group A Strep (GAS) Probe ASR.
Hologic, Inc.
DNA GAS PROBE (ASR)
In Commercial Distribution

  • 15420045511576 ()
PRD-05051

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent

Panther Fusion® - 15420045511552

Hologic GAS Plasmid Control.
Hologic, Inc.
LBLD, GAS PLASMID (UNASSAYED CONTROL)
In Commercial Distribution

  • 15420045511552 ()
PRD-05052

  • Beta-haemolytic Group A Streptococcus 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

Remel - 00848838063701

Xpect Flu A&B Control 20Swab/SET
REMEL, INC.
R246003
In Commercial Distribution

  • 30848838063702 ()
  • 00848838063701 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Rapid Response - 00722066003343

Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
BTNX Inc
FLUab-19C15
In Commercial Distribution

  • 00722066003343 ()
  • 00722066004241 ()
FLUab-19C15

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Poly stat - 00855574005407

Flu A & B, Immunochromatographic
POLYMEDCO, INC.
FLU22
In Commercial Distribution

  • 00855574005407 ()


  • Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical

ClearFit - 00855113008722

ClearFit 1.4cm Cover with Slot
LONGEVITI NEURO SOLUTIONS LLC
171738
In Commercial Distribution

  • 00855113008722 ()


  • Cranial resinous compound

CHORUS INFLUENZA B IgG - 08033891327538

No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS INFLUENZA A IgG - 08033891327514

No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Status Flu A+B card - 10743816001508

Status Flu A+B; 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-25-02
In Commercial Distribution

  • 10743816001508 ()
BSP-510-25-02

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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