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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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The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution

  • 10811877010880 ()


  • Influenza A/B virus antigen IVD, control
Control swabs intended for use only with Strep A product.
Alere Scarborough, Inc.
730-010
In Commercial Distribution

  • 10811877010446 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, control
Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution

  • 10811877010194 ()


  • Influenza A/B virus antigen IVD, control
No Description
DIASORIN SPA
310201
In Commercial Distribution

  • 08056771100205 ()


  • Hepatitis A virus total antibody IVD, control
VITROS Immunodiagnostic Products Anti-HAV Total Controls
ORTHO CLINICAL DIAGNOSTICS
6801463
In Commercial Distribution

  • 10758750001293 ()
6801463

  • Hepatitis A virus total antibody IVD, control
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30590 ()
BSB 3059

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB30580 ()
BSB 3058

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB30570 ()
BSB 3057

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30560 ()
BSB 3056

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB30550 ()
BSB 3055

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 1 ml
In Commercial Distribution

  • B502BSB30540 ()
BSB 3054

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2)
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB300570 ()
BSB 3005-7

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB300530 ()
BSB 3005-3

  • Total immunoglobulin A (IgA total) IVD, antibody
The IgA/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a TrisBuffered Saline solution (pH 7.2)
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB3005150 ()
BSB 3005-15

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB300510 ()
BSB 3005-1

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2).
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB3005050 ()
BSB 3005-05

  • Total immunoglobulin A (IgA total) IVD, antibody
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
IgA, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56650 ()
BSB 5665

  • Total immunoglobulin A (IgA total) IVD, control
IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56640 ()
BSB 5664

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56630 ()
BSB 5663

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56620 ()
BSB 5662

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56610 ()
BSB 5661

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56600 ()
BSB 5660

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56590 ()
BSB 5659

  • Total immunoglobulin A (IgA total) IVD, antibody
IgA Control Slides
BIO SB, INC.
BSB-9233-CS
In Commercial Distribution

  • B502BSB9233CS0 ()
BSB-9233-CS

  • Immunoglobulin A subclass (IgA subclass) IVD, control
George King Factor XIII Deficient plasma is fresh frozen human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-250.0
In Commercial Distribution

  • 00815696021150 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-100.0
In Commercial Distribution

  • 00815696020986 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-bulk
In Commercial Distribution

  • 00815696020955 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-50
In Commercial Distribution

  • 00815696020344 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-1.0
In Commercial Distribution

  • 00815696020337 ()


  • Coagulation factor XIII A subunit IVD, control
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