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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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Elecsys free PSA - 04015630940011

No Description
Roche Diagnostics GmbH
07027320190
In Commercial Distribution

  • 04015630940011 ()
07027320190

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

Elecsys Free PSA CalCheck - 04015630997053

No Description
Roche Diagnostics GmbH
03500373190
Not in Commercial Distribution

  • 04015630997053 ()
03500373190

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

IMMULITE® 2000 Systems fPS Free PSA - 00630414977478

fPS Free PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487239
In Commercial Distribution

  • 00630414977478 ()
L2KPF2(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE®1000 Systems fPS Free PSA - 00630414971575

fPS Free PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374043
In Commercial Distribution

  • 00630414971575 ()
LKPF1(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

DNA Controls SLIB Group Kit - 00858637005970

No Description
EXACT SCIENCES CORPORATION
100728
In Commercial Distribution

  • 00858637005970 ()


  • Exogenous DNA/RNA internal control IVD, kit

D CTRL 3 Kit - 00858637005444

No Description
EXACT SCIENCES CORPORATION
100303
In Commercial Distribution

  • 00858637005444 ()


  • Exogenous DNA/RNA internal control IVD, kit

D CTRL 2 Kit - 00858637005437

No Description
EXACT SCIENCES CORPORATION
100301
In Commercial Distribution

  • 00858637005437 ()


  • Exogenous DNA/RNA internal control IVD, kit

D CTRL 1 Kit - 00858637005420

No Description
EXACT SCIENCES CORPORATION
100300
In Commercial Distribution

  • 00858637005420 ()


  • Exogenous DNA/RNA internal control IVD, kit

Cologuard DNA Control Kit - 00858637005079

No Description
EXACT SCIENCES CORPORATION
100074
In Commercial Distribution

  • 00858637005079 ()


  • Exogenous DNA/RNA internal control IVD, kit

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
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