D3 Ultra 01-013502.V2

GUDID 30014613330455

Parainfluenza 1 DFA Reagent

DIAGNOSTIC HYBRIDS, INC.

Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay
Primary Device ID30014613330455
NIH Device Record Key54443522-c3fa-4a81-833a-a2f8a7017201
Commercial Distribution StatusIn Commercial Distribution
Brand NameD3 Ultra
Version Model Number01-013502.V2
Catalog Number01-013502.V2
Company DUNS117359612
Company NameDIAGNOSTIC HYBRIDS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130014613330455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GNWANTISERA, CF, INFLUENZA VIRUS A, B, C

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-15
Device Publish Date2019-03-07

On-Brand Devices [D3 Ultra]

30014613330479Parainfluenza 3 DFA Reagent
30014613330462Parainfluenza 2 DFA Reagent
30014613330455Parainfluenza 1 DFA Reagent
30014613330431Adeno DFA Reagent
30014613330424RSV DFA Reagent
30014613330417Influenza B DFA Reagent
30014613330394Influenza A DFA Reagent
30014613330387Influenza A DFA Reagent-BULK
30014613330370DFA Respiratory Virus Screening Reagent
30014613330363DFA Respiratory Virus Screening Reagent - Bulk
30014613330356D3 Ultra DFA Respiratory Virus ID Set
30014613330349D3 Ultra DFA Parainfluenza Reagent Set
30014613330325De Ultra DFA Influenza A/Influenza B Reagent Set
30014613330318D3 Ultra DFA RSV Reagent Set
30014613330301D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
30014613330295D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
30014613330288D3 Ultra DFA Respiratory Virus Screening and ID kit
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