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 Access hsTnI Calibrators are intended to calibrate the Access hsTnI assay for quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
C26909
In Commercial Distribution

  • 15099590707194 ()
C26909

  • Troponin I IVD, kit, chemiluminescent immunoassay
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).
Beckman Coulter, Inc.
B52669
In Commercial Distribution

  • 15099590693183 ()
B52699

  • Troponin I IVD, kit, chemiluminescent immunoassay
Rabbit Anti-Human Fibrinogen FIT- Conjugated 1 ml
Slmp, LLC
Rabbit Anti-Human Fibrinogen FIT- Conjugated 1 ml
In Commercial Distribution

  • 00810170550102 ()
FITC-006-01

  • Fibrinogen (Factor I) assay IVD, antibody
No Description
Ventana Medical Systems, Inc.
05267960001
In Commercial Distribution

  • 04015630971442 ()
05267960001

  • Fibrinogen (Factor I) assay IVD, antibody
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802301
In Commercial Distribution

  • 10758750002504 ()
  • 20758750002501 ()
6802301

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

  • 14560189210117 ()
  • 04560189210110 ()


  • Troponin I IVD, kit, enzyme immunoassay (EIA)
LOCI High-Sensitivity Troponin Calibrator
Siemens Healthcare Diagnostics Inc.
10719483
In Commercial Distribution

  • 00630414180380 ()
  • 00630414225227 ()
RC627

  • Troponin I IVD, calibrator
High-Sensitvity Troponin Calibrator Dimension Vista - CAL 5 Levels 2 VL/Level
Siemens Healthcare Diagnostics Inc.
10719482
In Commercial Distribution

  • 00630414180373 ()
  • 00630414225210 ()
KC627

  • Troponin I IVD, calibrator
A test for the quantitative measure of cross-linked N-telopeptides of Type I Collagen (NTx) in human serum as an indicator of bone resorption.
Alere Scarborough, Inc.
9021
Not in Commercial Distribution

  • 10811877010941 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (EIA) for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine.
Alere Scarborough, Inc.
9006
Not in Commercial Distribution

  • 10811877010934 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
11972316122
In Commercial Distribution

  • 04015630914142 ()
11972316122

  • Collagen type I cross-linked C-telopeptide IVD, calibrator
i-STAT hs-TnI cartridge
Abbott Point of Care Inc.
09P81-25
In Commercial Distribution

  • 00054749003051 ()
  • 10054749003058 ()
09P81-25

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211032 ()


  • Troponin I IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-3035
In Commercial Distribution

  • 05060169690943 ()


  • Collagen type I cross-linked C-telopeptide IVD, calibrator
ARCHITECT STAT Troponin-I Calibrators
ABBOTT LABORATORIES
2K41-01
In Commercial Distribution

  • 00380740003180 ()
02K4101

  • Troponin I IVD, calibrator
Cardiac Troponin I Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10445197
Not in Commercial Distribution

  • 00842768016738 ()
KC678

  • Troponin I IVD, calibrator
Cardiac Troponin-I Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10444896
In Commercial Distribution

  • 00842768013904 ()
  • 00630414003870 ()
RF521

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
LOCI Cardiac Troponin I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464336
In Commercial Distribution

  • 00842768022074 ()
RC621

  • Troponin I IVD, calibrator
Cardiac Troponin-I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444905
In Commercial Distribution

  • 00842768013836 ()
  • 00630414003931 ()
RF421C

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
Cardiac Troponin-I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10444986
In Commercial Distribution

  • 00842768013713 ()
  • 00630414016955 ()
RC421C

  • Troponin I IVD, calibrator
ARCHITECT STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
02R9801
In Commercial Distribution

  • 00380740175474 ()
02R9801

  • Troponin I IVD, calibrator
Alinity i STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
04Z2101
In Commercial Distribution

  • 00380740194048 ()
04Z2101

  • Troponin I IVD, calibrator
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
ZEUS SCIENTIFIC, INC.
XJ9021
In Commercial Distribution

  • 00845533002004 ()
XJ9021

  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
ZEUS SCIENTIFIC, INC.
NTx9021
In Commercial Distribution

  • 00845533001953 ()
XJ9021

  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.
ZEUS SCIENTIFIC, INC.
NTx9006
In Commercial Distribution

  • 00845533001878 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
ZEUS SCIENTIFIC, INC.
NTx9021
In Commercial Distribution

  • 00845533001861 ()


  • Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma.
BIOMERIEUX SA
30448-01
Not in Commercial Distribution

  • 03573026229115 ()


  • Troponin I IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
3825-300
In Commercial Distribution

  • 00816870020686 ()

  • Width: 7.75 Inch
3825-300B

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
3825-300
In Commercial Distribution

  • 00816870020679 ()

  • Width: 7.75 Inch
3825-300A

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
The Troponin I assay is intended for the quantitative determination of cardiac troponin I (cTnI) in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). For in vitro diagnostic use. 96 Tests.
POINTE SCIENTIFIC, INC.
CM1105-96
In Commercial Distribution

  • 00811727013347 ()
CM1105-96

  • Troponin I IVD, kit, enzyme immunoassay (EIA)
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
AC-03F1
In Commercial Distribution

  • 05060169690141 ()


  • Procollagen type I C-terminal propeptide (PICP) IVD, kit, enzyme immunoassay (EIA)
Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
405ab
In Commercial Distribution

  • 00850011135280 ()

  • 2 tests
405ab

  • Troponin T/Troponin I IVD, control
Validate High Sensitive Troponin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
405ro
In Commercial Distribution

  • 00859110005692 ()

  • 2 tests
405ro

  • Troponin T/Troponin I IVD, control
No Description
Roche Diagnostics GmbH
05095107160
In Commercial Distribution

  • 04015630939398 ()
05095107160

  • Troponin T/Troponin I IVD, control
No Description
Roche Diagnostics GmbH
3530469190
In Commercial Distribution

  • 04015630920068 ()
3530469190

  • Troponin T/Troponin I IVD, control
No Description
Roche Diagnostics GmbH
05915759190
In Commercial Distribution

  • 04015630942688 ()
05915759190

  • Troponin T/Troponin I IVD, control
No Description
Roche Diagnostics GmbH
11937553193
In Commercial Distribution

  • 04015630901234 ()
11937553193

  • Troponin T/Troponin I IVD, control
anti-Procollagen-1 Rat Monoclonal Antibody [M-58], Ready-To-Use, 15 mL
SAKURA FINETEK U.S.A., INC.
60-0222-15
In Commercial Distribution

  • 00615233008190 ()
60-0222-15

  • Procollagen type I N-terminal propeptide (PINP) IVD, control
No Description
adeor Medical AG
Low Profile Ultra Non-Stick Microbipolar Forceps
In Commercial Distribution

  • 04251388960264 ()
BIP-ATMI-06-IR

  • HLA class I antibody screening IVD, calibrator
No Description
Microgenics Corporation
CAI-UL
In Commercial Distribution

  • 00884883003620 ()


  • Troponin T/Troponin I IVD, control
No Description
CELL MARQUE CORPORATION
760-4435
In Commercial Distribution

  • 00841683100928 ()


  • Annexin A1 IVD, antibody
No Description
CELL MARQUE CORPORATION
221M-18
In Commercial Distribution

  • 00841683127963 ()


  • Annexin A1 IVD, antibody
No Description
CELL MARQUE CORPORATION
221M-17
In Commercial Distribution

  • 00841683127956 ()


  • Annexin A1 IVD, antibody
No Description
CELL MARQUE CORPORATION
221M-16
In Commercial Distribution

  • 00841683127949 ()


  • Annexin A1 IVD, antibody
No Description
CELL MARQUE CORPORATION
221M-15
In Commercial Distribution

  • 00841683127932 ()


  • Annexin A1 IVD, antibody
No Description
CELL MARQUE CORPORATION
221M-14
In Commercial Distribution

  • 00841683127925 ()


  • Annexin A1 IVD, antibody
For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex
For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex
For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

  • HLA class I antigen tissue typing IVD, kit, multiplex
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