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
DIAZYME LABORATORIES, INC.
DZ768A-CON
In Commercial Distribution

  • 00817089020696 ()


  • Fibrinogen assay (factor I) IVD, control
No Description
DIAZYME LABORATORIES, INC.
DZ768A-K
In Commercial Distribution

  • 00817089020672 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
Fibrinogen Control Slides
BIO SB, INC.
BSB-9179-CS
In Commercial Distribution

  • B502BSB9179CS0 ()
BSB-9179-CS

  • Fibrinogen assay (factor I) IVD, control
Fluorescein conjugated polyclonal goat antiserum to Human Fibrinogen
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761072 ()
107202

  • Fibrinogen assay (factor I) IVD, control
Goat antiserum to Human Fibrinogen
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761070 ()
107002

  • Fibrinogen assay (factor I) IVD, control
Fibrinogen Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB30530 ()
BSB 3053

  • Fibrinogen assay (factor I) IVD, control
Fibrinogen / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3004CS0 ()
BSB 3004-CS

  • Fibrinogen assay (factor I) IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen.
KAMIYA BIOMEDICAL COMPANY, LLC
K63C-10M
In Commercial Distribution

  • 00816426020870 ()
K63C-10M

  • Fibrinogen assay (factor I) IVD, control
No Description
TCOAG IRELAND LIMITED
T1414
In Commercial Distribution

  • 15391521420821 ()
  • 05391521420824 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
No Description
TCOAG IRELAND LIMITED
T1411
In Commercial Distribution

  • 15391521420814 ()
  • 05391521420817 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
No Description
TCOAG IRELAND LIMITED
T5104
In Commercial Distribution

  • 15391521420722 ()
  • 05391521420725 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
No Description
TCOAG IRELAND LIMITED
T1901
In Commercial Distribution

  • 15391521420500 ()
  • 05391521420503 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
No Description
TCOAG IRELAND LIMITED
T1302
In Commercial Distribution

  • 15391521420364 ()
  • 05391521420367 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
Troponin I Ultra Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10317626
In Commercial Distribution

  • 00630414515892 ()
2738323

  • Troponin I IVD, control
Troponin I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373707
In Commercial Distribution

  • 00630414971391 ()
LTICVM

  • Troponin I IVD, control
Calibrators for the assay of fibrinogen by the method of Clauss using Multifibren U
Siemens Healthcare Diagnostics Products GmbH
10873868
In Commercial Distribution

  • 00630414640631 ()
10873868

  • Fibrinogen assay (factor I) IVD, calibrator
ADVIA Centaur TNIH Master Curve Material Kit 5 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10994776
In Commercial Distribution

  • 00630414602936 ()
10994776

  • Troponin I IVD, control
TnI-Ultra Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995698
In Commercial Distribution

  • 00630414600116 ()
10995698

  • Troponin I IVD, control
High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml
Siemens Healthcare Diagnostics Inc.
10997842
In Commercial Distribution

  • 00630414006772 ()
10997842

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707958
Not in Commercial Distribution

  • 00842768037535 ()
  • 00630414006017 ()
KC683

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707957
Not in Commercial Distribution

  • 00842768037528 ()
  • 00630414006000 ()
KC682

  • Troponin I IVD, control
LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707956
Not in Commercial Distribution

  • 00842768037511 ()
  • 00630414005997 ()
KC681

  • Troponin I IVD, control
Calibrators for the assay of fibrinogen by the method of Clauss using Multifibren U
Siemens Healthcare Diagnostics Products GmbH
10446148
In Commercial Distribution

  • 00842768008276 ()
OQVK11

  • Fibrinogen assay (factor I) IVD, calibrator
VALIDATE B-CTx Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
304re
In Commercial Distribution

  • 00850011135662 ()


  • Collagen type I cross-linked C-telopeptide IVD, control
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-3030
In Commercial Distribution

  • 05060169690257 ()


  • Collagen type I cross-linked C-telopeptide IVD, control
ARCHITECT STAT Troponin-I Controls
ABBOTT LABORATORIES
2K41-10
In Commercial Distribution

  • 00380740003197 ()
02K4110

  • Troponin I IVD, control
ARCHITECT STAT High Sensitivity Troponin-I Controls
ABBOTT IRELAND
02R9810
In Commercial Distribution

  • 00380740175481 ()
02R9810

  • Troponin I IVD, control
Alinity i STAT High Sensitivity Troponin-I Controls
ABBOTT IRELAND
04Z2110
In Commercial Distribution

  • 00380740194055 ()
04Z2110

  • Troponin I IVD, control
No Description
HELENA LABORATORIES CORPORATION
5379
In Commercial Distribution

  • M52553790 ()


  • Fibrinogen assay (factor I) IVD, calibrator
i-STAT hs-TnI Control Level 3
Abbott Point of Care Inc.
06P17-23
In Commercial Distribution

  • 00054749004942 ()
06P17-23

  • Troponin I IVD, control
i-STAT hs-TnI Control Level 2
Abbott Point of Care Inc.
06P17-22
In Commercial Distribution

  • 00054749004935 ()
06P17-22

  • Troponin I IVD, control
i-STAT hs-TnI Control Level 1
Abbott Point of Care Inc.
06P17-21
In Commercial Distribution

  • 00054749004928 ()
06P17-21

  • Troponin I IVD, control
i-STAT hs-TnI Calibration Verification, Levels 1-3
Abbott Point of Care Inc.
06P17-20
In Commercial Distribution

  • 00054749004911 ()
06P17-20

  • Troponin I IVD, control
i-STAT cTnl, Calibration
ABBOTT POINT OF CARE INC.
06P17-12
In Commercial Distribution

  • 00054749001163 ()
  • 10054749001160 ()
06P17-12

  • Troponin I IVD, control
i-STAT cTnl, Control Level 3
ABBOTT POINT OF CARE INC.
06P17-11
In Commercial Distribution

  • 00054749001156 ()
  • 10054749001153 ()
06P17-11

  • Troponin I IVD, control
i-STAT cTnl, Control Level 2
ABBOTT POINT OF CARE INC.
06P17-10
In Commercial Distribution

  • 00054749001149 ()
  • 10054749001146 ()
06P17-10

  • Troponin I IVD, control
i-STAT cTnl, Control Level 1
ABBOTT POINT OF CARE INC.
06P17-09
In Commercial Distribution

  • 00054749001132 ()
  • 10054749001139 ()
06P17-09

  • Troponin I IVD, control
No Description
DIAZYME LABORATORIES, INC.
DZ768A-CAL
In Commercial Distribution

  • 00817089020689 ()


  • Fibrinogen assay (factor I) IVD, calibrator
No Description
Roche Diagnostics GmbH
08133859190
In Commercial Distribution

  • 07613336143162 ()
08133859190

  • Collagen type I cross-linked C-telopeptide IVD, control
For the calibration of the K-ASSAY® Fibrinogen assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-136C
In Commercial Distribution

  • 00816426021082 ()
KAI-136C

  • Fibrinogen assay (factor I) IVD, calibrator
For the calibration of the K-ASSAY® Fibrinogen assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-089C
Not in Commercial Distribution

  • 00816426020658 ()
KAI-089C

  • Fibrinogen assay (factor I) IVD, calibrator
FITC anti-Fibrinogen Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8538-C010
In Commercial Distribution

  • 00615233002334 ()
8538-C010

  • Fibrinogen (Factor I) assay IVD, antibody
Troponin I - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10317708
In Commercial Distribution

  • 00630414516219 ()
2789602

  • Troponin I IVD, kit, chemiluminescent immunoassay
TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
PHC CORPORATION
N/A
In Commercial Distribution

  • 04987595301803 ()
301803

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
PHC CORPORATION
N/A
In Commercial Distribution

  • 04987595301131 ()


  • Troponin I IVD, kit, chemiluminescent immunoassay
Troponin I - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10317709
In Commercial Distribution

  • 00630414516226 ()
2790309

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642239
In Commercial Distribution

  • 00630414986098 ()
L2KTI2(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642238
Not in Commercial Distribution

  • 00630414986081 ()
LSKTI1(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
No Description
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10642237
In Commercial Distribution

  • 00630414986074 ()
LKTI1(D)

  • Troponin I IVD, kit, chemiluminescent immunoassay
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