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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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Low-Tox®-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3335
Not in Commercial Distribution

  • 06284510990202 ()

  • Total Volume: 10 Milliliter
CL3335

  • Complement reagent IVD
Low-Tox-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3331
Not in Commercial Distribution

  • 06284510990196 ()

  • Total Volume: 10 Milliliter
CL3331

  • Complement reagent IVD
Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3120
Not in Commercial Distribution

  • 06284510990165 ()

  • Total Volume: 100 Milliliter
CL3120

  • Complement reagent IVD
Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3115
Not in Commercial Distribution

  • 06284510990158 ()

  • Total Volume: 25 Milliliter
CL3115

  • Complement reagent IVD
Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3113
Not in Commercial Distribution

  • 06284510990141 ()

  • Total Volume: 3 Milliliter
CL3113

  • Complement reagent IVD
Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3112
Not in Commercial Distribution

  • 06284510990134 ()

  • Total Volume: 20 Milliliter
CL3112

  • Complement reagent IVD
Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3111
Not in Commercial Distribution

  • 06284510990127 ()

  • Total Volume: 25 Milliliter
CL3111

  • Complement reagent IVD
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution

  • 00860424000259 ()
PSP-101

  • Tendon graft
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
NANOSPHERE, INC.
20-011-024
Not in Commercial Distribution

  • 00857573006324 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution

  • 00857573006317 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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