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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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A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-200
In Commercial Distribution

  • 10811877011337 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Control swabs intended for use only with BinaxNOW COVID-19 Ag product manufactured by Abbott Diagnostics Scarborough, Inc.
Alere Scarborough, Inc.
195-080
In Commercial Distribution

  • 10811877011306 ()


  • SARS-CoV-2 antigen IVD, control
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals who are suspected of COVID-19 by their healthcare provider.
Alere Scarborough, Inc.
195-000
In Commercial Distribution

  • 10811877011290 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs
Alere Scarborough, Inc.
190-080
Not in Commercial Distribution

  • 10811877011276 ()


  • SARS-CoV-2 nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
WatMIND USA
RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 10810172700090 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 10810172700083 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
Neumodx Molecular, Inc.
300800
In Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
SANIZIDE PLUS WIPES LG BULK NITRILE EXAM GLOVES 2/BAG ABSORBENT POWDER 2OZ HEAT SEALED BAG SCOOP / SPATULA PLASTIC BULK NON-SURGICAL GOWNS PAPER TOWELS BULK FACE MASK W/SHIELD BIOHAZARD BAG 24X24 BULK ANTIMICROBIAL WIPES "PAWS" BAG PLASTIC 10X12" RECLOSABLE TWIST TIES (GREEN)
ULINE, INC.
S-25621
In Commercial Distribution

  • 10850015055642 ()


  • First aid kit, medicated
3X3" STERILE GAUZE PAD (2 PACK) HAND SANITIZER 0.9GM BULK NITRILE EXAM GLOVES 2/BAG BZK WIPES, FAO, 5X7 SINGLE WIPE ALCOHOL PREP PAD, FAO, SOLDIER, STERILE NEOMMYCIN ANTIBIOTIC OINTMENT 0.9G BULK BANDAGE PLASTIC 1X3" 5-UP 1X3" FABRIC ADHESIVE BANDAGES 5-UP 2"X4YD NS GAUZE ROLL BULK 5"X9" COMBINE DRESSING BULK EMERGENCY BLANKET
ULINE, INC.
S-25619
In Commercial Distribution

  • 10850015055628 ()


  • First aid kit, medicated
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