D3 01-045005

GUDID 30014613330554

CTMAB CONJUGATE

DIAGNOSTIC HYBRIDS, INC.

Multiple Chlamydia species antigen IVD, reagent
Primary Device ID30014613330554
NIH Device Record Key8ea3d442-77c0-40ec-943a-337a72fbe125
Commercial Distribution StatusIn Commercial Distribution
Brand NameD3
Version Model Number01-045005
Catalog Number01-045005
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 Kitfalse
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
GS130014613330554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJPANTISERUM, FLUORESCENT, CHLAMYDIA TRACHOMATIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-22
Device Publish Date2018-07-22

On-Brand Devices [D3]

30014613330738HSV-2 MAB CONJUGATE
30014613330721HSV-1 MAB CONJUGATE
30014613330714DFA HSV TYPING REAGENT DUO PK
30014613330707D3 DFA HSV ID AND TYPING KIT
30014613330691HSV MAB CONJUGATE
30014613330684D3 DFA HERPES SIMPLEX ID KIT
30014613330677CMV IEA MAB CONJUGATE
30014613330660D3 DFA Cytomegalovirus ID Kit
30014613330639Anti- Mouse Conjugate - Bulk
30014613330622Anti-Mouse Conjugate
30014613330615ENTERO MAB REAGENT 500ML
30014613330608Enterovirus Reagent
30014613330592EV MAB CONJUGATE
30014613330585D3 Enterovirus Duo Pack
30014613330578Enterovirus Reagent BULK 1 LITER
30014613330561D3 IFA Enterovirus Identification Kit
30014613330554CTMAB CONJUGATE
30014613330547D3 DFA CHLM CULT CONF KIT
30014613330530MPV MAB CONJUGATE
30014613330523MPV/DFA REAGENT 2ML
30014613330516MPV DFA KIT
30014613330509VZV DFA REAGENT
30014613330493D3 DFA Varicella-zoster Virus Kit
30014613330448D3 DFA 500 ML SCR REAGENT
30014613330400Influenza B DFA Reagent-BULK
30014613330271Mounting Fluid (15mL) (pH 7.0-7.4)
3001461333025740X Wash Solution Concentrate
30014613330240RSV Antigen Control Slides
30014613330233CMV Antigen Control Slide
30014613338703CMV Antigen Control Slides
30014613338697Chlamydia Antigen Control Slides
30014613338680hMPV Antigen Control Slides
30014613338673VZV Antigen Control Slides
30014613338666HSV-1/HSV-2 Antigen Control Slides
30014613338642Respiratory Virus Antigen Control Slides (8 well slide, 7 viruses, 1 negative well)
30014613338611CMV Control Stock
30014613338604HSV-2 Control Stock
30014613338598HSV-1 Control Stock
30014613338581hMPV Virus Control Stock
30014613338574Parainfluenza 3 Virus Control Stock
30014613338567Parainfluenza 2 Virus Control Stock
30014613338550Parainfluenza 1 Virus Control Stock
30014613338543Adenovirus Control Stock
30014613338536RSV Virus Control Stock
30014613338529Influenza B Virus Control Stock
30014613338512Influenza A Virus Control Stock
30014613338505Respiratory Control Stock
30014613338499VZV Control Stock (Single Use) (shipped frozen)
30014613338482Chlamydia trachomatis, LGV Strain
30014613330950DOUBLE DUET RESPIRATORY KIT

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