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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No Description
CELL MARQUE CORPORATION
352A-75
In Commercial Distribution

  • 00841683138136 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352A-74
In Commercial Distribution

  • 00841683138129 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271R-24
In Commercial Distribution

  • 00841683101666 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271R-27
In Commercial Distribution

  • 00841683101550 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4867
In Commercial Distribution

  • 00841683101505 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271R-26
In Commercial Distribution

  • 00841683101123 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271R-25
In Commercial Distribution

  • 00841683101024 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
760-6081
In Commercial Distribution

  • 00841683119883 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
760-2834
Not in Commercial Distribution

  • 00841683110842 ()


  • Inhibin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-90
In Commercial Distribution

  • 00841683105626 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4446
In Commercial Distribution

  • 00841683101031 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352R-16
In Commercial Distribution

  • 00841683121510 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352R-14
In Commercial Distribution

  • 00841683121503 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-96
In Commercial Distribution

  • 00841683121497 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
352M-94
In Commercial Distribution

  • 00841683121480 ()


  • Napsin A IVD, antibody
No Description
CELL MARQUE CORPORATION
271R-28
In Commercial Distribution

  • 00841683117643 ()


  • Inhibin A IVD, antibody
For the calibration of the K-ASSAY® Lp(a) assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-018C
In Commercial Distribution

  • 00816426020573 ()
KAI-018C

  • Lipoprotein A IVD, calibrator
For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-044
In Commercial Distribution

  • 00816426020245 ()
KAI-044

  • Lipoprotein A IVD, reagent
For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-017
Not in Commercial Distribution

  • 00816426020122 ()
KAI-017

  • Lipoprotein A IVD, reagent
Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.
SENTINEL CH. SPA
11522D
In Commercial Distribution

  • 08058056680228 ()
11522D

  • Lipoprotein A IVD, calibrator
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
SENTINEL CH. SPA
11504D
In Commercial Distribution

  • 08058056680211 ()
11504D

  • Lipoprotein A IVD, reagent
Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, according to the indicated analytical procedure.
SENTINEL CH. SPA
1152201
In Commercial Distribution

  • 08058056681744 ()
1152201

  • Lipoprotein A IVD, control
Napsin A 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

  • B502BSB33970 ()
BSB 3397

  • Napsin A IVD, antibody
Napsin A 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

  • B502BSB33960 ()
BSB 3396

  • Napsin A IVD, antibody
Napsin A 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

  • B502BSB33950 ()
BSB 3395

  • Napsin A IVD, antibody
Tinto Napsin A 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

  • B502BSB33940 ()
BSB 3394

  • Napsin A IVD, antibody
Tinto Napsin A 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

  • B502BSB33930 ()
BSB 3393

  • Napsin A IVD, antibody
Tinto Napsin A 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

  • B502BSB33920 ()
BSB 3392

  • Napsin A IVD, antibody
Inhibin alpha Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB33620 ()
BSB 3362

  • Inhibin A IVD, control
Inhibin alpha is a rabbit 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

  • B502BSB33610 ()
BSB 3361

  • Inhibin A IVD, antibody
Inhibin alpha is a rabbit 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

  • B502BSB33600 ()
BSB 3360

  • Inhibin A IVD, antibody
Inhibin alpha is a rabbit 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

  • B502BSB33590 ()
BSB 3359

  • Inhibin A IVD, antibody
Tinto Inhibin alpha is a rabbit 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

  • B502BSB33580 ()
BSB 3358

  • Inhibin A IVD, antibody
Tinto Inhibin alpha is a rabbit 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

  • B502BSB33570 ()
BSB 3357

  • Inhibin A IVD, antibody
Tinto Inhibin alpha is a rabbit 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

  • B502BSB33560 ()
BSB 3356

  • Inhibin A IVD, antibody
TintoFast Chromogranin A 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.
BSB-3773-7
In Commercial Distribution

  • B502BSB377370 ()

  • Total Volume: 7 Milliliter
BSB-3773-7

  • Chromogranin A IVD, antibody
TintoFast Chromogranin A 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.
BSB-3773-3
In Commercial Distribution

  • B502BSB377330 ()

  • Total Volume: 3 Milliliter
BSB-3773-3

  • Chromogranin A IVD, antibody
TintoFast Chromogranin A 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.
BSB-3773-15
In Commercial Distribution

  • B502BSB3773150 ()

  • Total Volume: 15 Milliliter
BSB-3773-15

  • Chromogranin A IVD, antibody
No Description
DIAZYME LABORATORIES, INC.
DZ131B-CON
In Commercial Distribution

  • 00817089020399 ()


  • Lipoprotein A IVD, control
No Description
DIAZYME LABORATORIES, INC.
DZ131B-CAL
In Commercial Distribution

  • 00817089020382 ()


  • Lipoprotein A IVD, calibrator
No Description
DIAZYME LABORATORIES, INC.
DZ131A-CON
In Commercial Distribution

  • 00817089020375 ()


  • Lipoprotein A IVD, control
No Description
DIAZYME LABORATORIES, INC.
DZ131A-CAL
In Commercial Distribution

  • 00817089020368 ()


  • Lipoprotein A IVD, calibrator
Inhibin alpha, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56930 ()
BSB 5693

  • Inhibin A IVD, control
Inhibin alpha 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

  • B502BSB56920 ()
BSB 5692

  • Inhibin A IVD, antibody
Inhibin alpha 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

  • B502BSB56910 ()
BSB 5691

  • Inhibin A IVD, antibody
Inhibin alpha 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

  • B502BSB56900 ()
BSB 5690

  • Inhibin A IVD, antibody
Tinto Inhibin alpha 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

  • B502BSB56890 ()
BSB 5689

  • Inhibin A IVD, antibody
Tinto Inhibin alpha 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

  • B502BSB56880 ()
BSB 5688

  • Inhibin A IVD, antibody
Tinto Inhibin alpha 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

  • B502BSB56870 ()
BSB5687

  • Inhibin A IVD, antibody
Chromogranin A, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB53500 ()
BSB 5350

  • Chromogranin A IVD, control
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