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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D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
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
IgA / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3005CS0 ()
BSB 3005-CS

  • Immunoglobulin A antibody (anti-IgA) IVD, control
Lp (a) Lipoprotein BL-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL-204B
In Commercial Distribution

  • 00817302022315 ()

  • Kit contains 2 R1 and 2 R2 bottles
  • Total Volume: 18 Milliliter
  • Total Volume: 7 Milliliter
BL-204B

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Lp (a) Lipoprotein AU-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-204B
In Commercial Distribution

  • 00817302022308 ()

  • Total Volume: 45 Milliliter
  • Total Volume: 15 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles
AU-204B

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

  • 04015630930586 ()
5852633190

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

  • 04015630929962 ()
5852625190

  • 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
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
OPAI010T60
In Commercial Distribution

  • 00847627025173 ()


  • Chromogranin 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
AVI010G
In Commercial Distribution

  • 00847627024190 ()


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

  • 00847627010636 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM171A
In Commercial Distribution

  • 00847627006707 ()


  • Inhibin 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
BIOCARE MEDICAL LLC
NPAI010T40
In Commercial Distribution

  • 00847627037718 ()


  • 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
No Description
THE BINDING SITE GROUP LIMITED
LK098.S
Not in Commercial Distribution

  • 05051700016841 ()


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

  • 00380740054267 ()
07K0040

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Influenza A Virus Control Stock
DIAGNOSTIC HYBRIDS, INC.
20-4710010
In Commercial Distribution

  • 30014613338512 ()
20-4710010

  • Influenza A virus antigen IVD, control
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
Roche Diagnostics GmbH
05852625160
In Commercial Distribution

  • 07613336237397 ()
05852625160

  • 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
Roche Diagnostics GmbH
05852633160
In Commercial Distribution

  • 07613336237403 ()
05852633160

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

  • 07613336237380 ()
08106126160

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Axilum Robotics TMS-Explorer Tracking System for TMS-Cobot TS MV
AXILUM ROBOTICS
TMS-Explorer-1
In Commercial Distribution

  • 03701354630116 ()
3-01-01

  • Magnetic neural stimulation system
TMS coil adaptation kit for MagVenture Cool-B65-A/P-CO coil, for TMS-Cobot TS MV
AXILUM ROBOTICS
ADAP-MAGV-CB65AP-11
In Commercial Distribution

  • 03701354620285 ()
2-02-08

  • Magnetic neural stimulation system
Coil adaptation kit for MagVenture Cool-B65-CO coil, for TMS-Cobot TS MV
AXILUM ROBOTICS
ADAP-MAGV-CB65A-11
In Commercial Distribution

  • 03701354620261 ()
2-02-06

  • Magnetic neural stimulation system
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