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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Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510204
In Commercial Distribution

  • 00858400005022 ()


  • Anti-Kp^a red blood cell grouping IVD, antibody
No Description
FUJIREBIO DIAGNOSTICS, INC.
4008086
In Commercial Distribution

  • 00869164000079 ()

  • 100 tests per kit


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279910
Not in Commercial Distribution

  • 00840733101328 ()
279910

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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
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
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
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
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
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
No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3923
Not in Commercial Distribution

  • 00840487100219 ()
3923

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
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
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
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
Anti-Jka (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721380
In Commercial Distribution

  • 10758750004140 ()
721380

  • Anti-Jk^a red blood cell grouping IVD, antibody
ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0
ORTHO-CLINICAL DIAGNOSTICS, INC.
715280
In Commercial Distribution

  • 10758750003389 ()
715280

  • Anti-Le^a red blood cell grouping IVD, antibody
ANTI-FYA (ANTI-DUFFY A) 1X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
715130
In Commercial Distribution

  • 10758750003365 ()
715130

  • Anti-Fy^a red blood cell grouping IVD, antibody
ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
Diagnostic Automation, Inc.
DACD330-50
In Commercial Distribution

  • 00894175000619 ()

  • 50 Tests/Kit
330-50

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z164U
In Commercial Distribution

  • 05060242472497 ()
  • 05060242472480 ()
  • 05060242472503 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z162U
In Commercial Distribution

  • 05060242471704 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.
ALBA BIOSCIENCE LIMITED
Z152U
In Commercial Distribution

  • 05060242471698 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z231U
In Commercial Distribution

  • 05060242471056 ()


  • Anti-Wr^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z212U
In Commercial Distribution

  • 05060242471025 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z151U
Not in Commercial Distribution

  • 05060242470974 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
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 Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
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
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
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
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
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
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
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
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
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
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
Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
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
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
anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8487-C010
In Commercial Distribution

  • 00615233010131 ()
8487-C010

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody
anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8487-M100
In Commercial Distribution

  • 00615233010124 ()
8487-M100

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Cyclosporine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10335454
In Commercial Distribution

  • 00630414524481 ()
4567682

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995549
In Commercial Distribution

  • 00630414598734 ()
  • 00842768027383 ()
10995549

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
CSA Pretreatment - CENTAUR - CONS - 2x26mL
Siemens Healthcare Diagnostics Inc.
10335453
In Commercial Distribution

  • 00630414524474 ()
  • 00630414003689 ()
4567127

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
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