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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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Inocu Swabs - 10634853001302

MSSE Negative Control
MICROBIOLOGICS INC.
MSSE-01
In Commercial Distribution

  • 10634853001302 ()
MSSE-01

  • PCR/NAT negative control IVD

Inocu Swabs - 10634853001296

MRSA Negative
MICROBIOLOGICS INC.
MRSA-02
In Commercial Distribution

  • 10634853001296 ()
MRSA-02

  • PCR/NAT negative control IVD

Inocu Swabs - 10634853001289

MRSA Positive
MICROBIOLOGICS INC.
MRSA-01
In Commercial Distribution

  • 10634853001289 ()
MRSA-01

  • MRSA nucleic acid IVD, control

Inocu Swabs - 10634853001272

Group B Strep Negative
MICROBIOLOGICS INC.
GBS-02
In Commercial Distribution

  • 10634853001272 ()
GBS-02

  • PCR/NAT negative control IVD

Inocu Swabs - 10634853001265

Group B Strep Positive
MICROBIOLOGICS INC.
GBS-01
In Commercial Distribution

  • 10634853001265 ()
GBS-01

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Inocu Swabs - 10634853001258

CT/GC Swab Validation Set (Chlamydia/GC)
MICROBIOLOGICS INC.
CTGC-VP
In Commercial Distribution

  • 10634853001258 ()
CTGC-VP

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Inocu Swabs - 10634853001227

VRE Positive (Van B)
MICROBIOLOGICS INC.
CE VRE-03
In Commercial Distribution

  • 10634853001227 ()
CE VRE-03

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control

Inocu Swabs - 10634853001210

VRE Negative
MICROBIOLOGICS INC.
CE VRE-02
In Commercial Distribution

  • 10634853001210 ()
CE VRE-02

  • PCR/NAT negative control IVD

Inocu Swabs - 10634853001203

VRE Positive (Van A)
MICROBIOLOGICS INC.
CE VRE-01
In Commercial Distribution

  • 10634853001203 ()
CE VRE-01

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control

Microorganism Pellets - 10634853000589

Culture Control Kit for Uricult
MICROBIOLOGICS INC.
URI-KIT
In Commercial Distribution

  • 10634853000589 ()
URI-KIT

  • Multiple urine analyte IVD, control
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