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 Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated
Acute Hemodialysis Tray
ARGON MEDICAL DEVICES, INC.
500320F
Not in Commercial Distribution

  • 20886333215830 ()
  • 00886333215836 ()
500320F

  • General surgical procedure kit, medicated
Hemodialysis Pack
ARGON MEDICAL DEVICES, INC.
500326D
Not in Commercial Distribution

  • 20886333215847 ()
  • 00886333215843 ()
500326D

  • General surgical procedure kit, medicated
No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Wallac Oy
B064-112
Not in Commercial Distribution

  • 06438147344420 ()
B064-112

  • Inhibin A IVD, kit, fluorescent immunoassay
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Wallac Oy
B064-112-P2
Not in Commercial Distribution

  • 06438147344406 ()
B064-112-P2

  • Inhibin A IVD, kit, fluorescent immunoassay
FLEX Polyclonal Rabbit Anti-Human IgA Ready-to-Use (Dako Omnis)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GA510
In Commercial Distribution

  • 05700572034094 ()

  • Total Volume: 12 Milliliter


  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP3403
In Commercial Distribution

  • 05055273204421 ()
LP3403

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
For the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP2878
Not in Commercial Distribution

  • 05055273204384 ()
LP2878

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA7157
In Commercial Distribution

  • 05055273203905 ()
IA7157

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA3895
Not in Commercial Distribution

  • 05055273203899 ()
IA3895

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA3832
In Commercial Distribution

  • 05055273203882 ()
IA3832

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA2447
Not in Commercial Distribution

  • 05055273203820 ()
IA2447

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP2757
In Commercial Distribution

  • 05055273209198 ()
LP2757

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
5852625190
In Commercial Distribution

  • 04015630929962 ()
5852625190

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
5852633190
In Commercial Distribution

  • 04015630930586 ()
5852633190

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Quantia Lipoprotein(a)
ABBOTT LABORATORIES
7K00-40
In Commercial Distribution

  • 00380740054267 ()
07K0040

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Quantia Lipoprotein(a)
ABBOTT LABORATORIES
07K0041
In Commercial Distribution

  • 00380740156435 ()
07K0041

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Alinity c Lp(a) Reagent Kit 200 Tests
ABBOTT LABORATORIES
01R1421
In Commercial Distribution

  • 00380740153847 ()
01R1421

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK098.S
Not in Commercial Distribution

  • 05051700016841 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
BIOCARE MEDICAL LLC
OPAI010T60
In Commercial Distribution

  • 00847627025173 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
AVI010G
In Commercial Distribution

  • 00847627024190 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
NPAI010T40
In Commercial Distribution

  • 00847627037718 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
PM010AA
In Commercial Distribution

  • 00847627010636 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446069
In Commercial Distribution

  • 00842768007552 ()
  • 00842768019067 ()
OQHL11

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
anti-IgA Rabbit Monoclonal Antibody [EP170], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8381-C010
In Commercial Distribution

  • 00615233001931 ()
8381-C010

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
anti-IgA Rabbit Monoclonal Antibody [EP170], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8381-M250
In Commercial Distribution

  • 00615233001924 ()
8381-M250

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
No Description
BIOCARE MEDICAL LLC
CM171A
In Commercial Distribution

  • 00847627006707 ()


  • Inhibin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
IP010G10
In Commercial Distribution

  • 00847627008459 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010C
In Commercial Distribution

  • 00847627005519 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010B
In Commercial Distribution

  • 00847627005502 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010A
In Commercial Distribution

  • 00847627005496 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
Roche Diagnostics GmbH
05852633160
In Commercial Distribution

  • 07613336237403 ()
05852633160

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
05852625160
In Commercial Distribution

  • 07613336237397 ()
05852625160

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08106126160
In Commercial Distribution

  • 07613336237380 ()
08106126160

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
08106126190
In Commercial Distribution

  • 07613336140833 ()
08106126190

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
BIOGENEX LABORATORIES
PU045-5UP
In Commercial Distribution

  • 00810119679895 ()

  • Total Volume: 0.5 Milliliter
PU045-5UP

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
No Description
DIAZYME LABORATORIES, INC.
DZ131B-K
In Commercial Distribution

  • 00817089021662 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
DIAZYME LABORATORIES, INC.
DZ131A-KY1
In Commercial Distribution

  • 00817089020986 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
DIAZYME LABORATORIES, INC.
DZ131A-KB1
In Commercial Distribution

  • 00817089020979 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
DIAZYME LABORATORIES, INC.
DZ131A-K
In Commercial Distribution

  • 00817089020351 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
IgA Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36850 ()
BSB 3685

  • Immunoglobulin A antibody (anti-IgA) IVD, control
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