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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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IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0136
Not in Commercial Distribution

  • 00815381020291 ()
RFIT-ASY-0136

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0145
In Commercial Distribution

  • 00815381020185 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0144
In Commercial Distribution

  • 00815381020178 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0130
Not in Commercial Distribution

  • 00815381020161 ()
RFIT-ASY-0130

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0129
Not in Commercial Distribution

  • 00815381020154 ()
RFIT-ASY-0129

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress CoV-2/Flu/RSV plus
CEPHEID
XPRS4PLEX-10
In Commercial Distribution

  • 07332940008604 ()
XPRS4PLEX-10

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369137 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
5 tests/kit
In Commercial Distribution

  • 06974849369120 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical
Inst: Scissor Curv 4.5in B/B 20/Bx
MEDICAL ACTION INDUSTRIES INC.
73649
In Commercial Distribution

  • 20809160003739 ()
  • 10809160003732 ()
  • 30809160003736 ()


  • General-purpose surgical scissors, single-use
Operating Scissors 6 1/2" cvd b/b
GSOURCE LLC
gS 13.4036
In Commercial Distribution

  • 00840314201744 ()
gS 13.4036

  • Bandage scissors, reusable
Operating Scissors 6 1/2" str b/b
GSOURCE LLC
gS 13.4033
In Commercial Distribution

  • 00840314201713 ()
gS 13.4033

  • Bandage scissors, reusable
Operating Scissors 5 1/2" cvd b/b
GSOURCE LLC
gS 13.4026
In Commercial Distribution

  • 00840314201676 ()
gS 13.4026

  • Bandage scissors, reusable
Operating Scissors 5 1/2" str b/b
GSOURCE LLC
gS 13.4023
In Commercial Distribution

  • 00840314201645 ()
gS 13.4023

  • Bandage scissors, reusable
Operating Scissors 4 1/2" cvd b/b
GSOURCE LLC
gS 13.4006
In Commercial Distribution

  • 00840314201522 ()
gS 13.4006

  • Bandage scissors, reusable
Operating Scissors 4 1/2" str b/b
GSOURCE LLC
gS 13.4003
In Commercial Distribution

  • 00840314201492 ()
gS 13.4003

  • Bandage scissors, reusable
Deaver Scissors 5-1/2" (14cm), straight B/B
Hayden Medical, Inc.
100-104
In Commercial Distribution

  • 00840319735916 ()
100-104

  • General-purpose surgical scissors, reusable
Operating Scissors 6-1/2" (16.3cm), curved B/B
Hayden Medical, Inc.
100-058
In Commercial Distribution

  • 00840319701164 ()
100-058

  • General-purpose surgical scissors, reusable
Operating Scissors 5-1/2" (13.8cm), curved B/B
Hayden Medical, Inc.
100-056
In Commercial Distribution

  • 00840319701157 ()
100-056

  • General-purpose surgical scissors, reusable
Operating Scissors 4-1/2" (11.3cm), curved B/B
Hayden Medical, Inc.
100-052
In Commercial Distribution

  • 00840319701133 ()
100-052

  • General-purpose surgical scissors, reusable
Operating Scissors 6-1/2" (16.3cm), straight B/B
Hayden Medical, Inc.
100-028
In Commercial Distribution

  • 00840319701027 ()
100-028

  • General-purpose surgical scissors, reusable
Operating Scissors 5-1/2" (13.8cm), straight B/B
Hayden Medical, Inc.
100-026
In Commercial Distribution

  • 00840319701003 ()
100-026

  • General-purpose surgical scissors, reusable
Operating Scissors 4-1/2" (11.3cm), straight B/B
Hayden Medical, Inc.
100-022
In Commercial Distribution

  • 00840319700983 ()
100-022

  • General-purpose surgical scissors, reusable
g2 Stevens Tenotomy Scissors 4" cvd b/b
GSOURCE LLC
SC.13.2720
In Commercial Distribution

  • 00840314250711 ()
SC.13.2720

  • Tenotome
g2 Stevens Tenotomy Scissors 4" str b/b
GSOURCE LLC
SC.13.2680
In Commercial Distribution

  • 00840314250704 ()
SC.13.2680

  • Tenotome
O.R. Sci, B/B, cvd, 6 1/2"
Avalign Technologies, Inc.
VM21-4184
In Commercial Distribution

  • 00190776235383 ()


  • General-purpose surgical scissors, reusable
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