D3 Fastpoint 01-120002

GUDID 30014613330813

D3 FASTPOINT RSV/MPV KIT

DIAGNOSTIC HYBRIDS, INC.

Multiple respiratory virus antigen IVD, kit, multiplex
Primary Device ID30014613330813
NIH Device Record Key10fd7c04-9be6-4660-934e-c981f709bbab
Commercial Distribution StatusIn Commercial Distribution
Brand NameD3 Fastpoint
Version Model NumberRSV/MPV ID Kit
Catalog Number01-120002
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
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
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130014613330813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMGAntisera, fluorescent, human metapneumovirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [D3 Fastpoint]

30014613330875L-DFA Parainfluenza Virus/Adenovirus Reagent
30014613330868L-DFA RSV/MPV Reagent
30014613330851L-DFA Influenza A/Influenza B Reagent
30014613330844Re-Suspension Buffer
30014613330837FASTPOINT RSV/MPV KIT BX 2
30014613330820FASTPOINT RSV/MPV KIT BX 1
30014613330813D3 FASTPOINT RSV/MPV KIT
30014613330806FASTPOINT FLUA/B KIT BX 2
30014613330790FASTPOINT FLUA/B KIT BX 1
30014613330783FASTPOINT FLUA/B KIT
30014613330776D3 FASTPOINT LDFA VIR IDKIT BX
30014613330769D3 FASTPOINT LDFA VIR IDKIT BX
30014613330752D3 FASTPOINT RESP VIRUS ID KIT
30014613338727L-DFA RSV/MPV Antigen Control Slides
30014613338710L-DFA Influenza A/Influenza B Antigen Control Slides

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