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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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Influenza A DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013100.V2-BULK
In Commercial Distribution

  • 30014613330387 ()
01-013100.V2-BULK

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay
DFA Respiratory Virus Screening Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013010.V2
In Commercial Distribution

  • 30014613330370 ()
01-013010.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
DFA Respiratory Virus Screening Reagent - Bulk
DIAGNOSTIC HYBRIDS, INC.
01-013000.V2-BULK
In Commercial Distribution

  • 30014613330363 ()
01-013000.V2-BULK

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Lgc Clinical Diagnostics, Inc.
2000-0100
In Commercial Distribution

  • 00860006589783 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00860006589776 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0080
In Commercial Distribution

  • 00860006589707 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
Xpect C. diff Toxin A/B KT/40TST
REMEL, INC.
R24640
In Commercial Distribution

  • 30848838068417 ()
  • 00848838068416 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
ABBOTT PRISM Positive Run Control Kit
ABBOTT LABORATORIES
3E60-11
Not in Commercial Distribution

  • 00380740039219 ()
03E6011

  • Multiple blood-borne virus antigen/antibody IVD, control
ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102C
In Commercial Distribution

  • 00847661005780 ()
00102C

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102B
In Commercial Distribution

  • 00847661005773 ()
00102B

  • Multiple blood-borne virus antigen/antibody IVD, control
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