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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Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution

  • M70883113970 ()
  • M70885113983 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
6 Panel Oral Fluid Test, AMP-BZO-COC-MET-OPI-THC
Express Diagnostic Int'l, Inc.
80600-EI
In Commercial Distribution

  • B29880600EI0 ()
80600-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC
Express Diagnostic Int'l, Inc.
71021
In Commercial Distribution

  • B2987102110 ()
71021

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC
Express Diagnostic Int'l, Inc.
71020
In Commercial Distribution

  • B2987102010 ()
71020

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Cup Drug Test, AMP-BUP-BZO-COC-MET-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
70809
In Commercial Distribution

  • B2987080910 ()
70809

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI-THC
Express Diagnostic Int'l, Inc.
70600
In Commercial Distribution

  • B2987060010 ()
70600

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI
Express Diagnostic Int'l, Inc.
70542
In Commercial Distribution

  • B2987054210 ()
70542

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Cup Drug Test, COC-MET-OPI300-THC
Express Diagnostic Int'l, Inc.
70410
In Commercial Distribution

  • B2987041010 ()
70410

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC
EXPRESS DIAGNOSTICS INT'L, INC.
65515
Not in Commercial Distribution

  • B298655150 ()
65515

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
61401
Not in Commercial Distribution

  • B298614010 ()
61401

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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