BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay 441126

GUDID 00382904411268

BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay Reagent Pack Contains: 12 each 96 Microwells: CT Q? Priming, CT Q? Amplification

BECTON, DICKINSON AND COMPANY

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00382904411268
NIH Device Record Keyab086da1-2fa1-4122-a70c-86164969ab94
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay
Version Model Number441126
Catalog Number441126
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
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(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904411268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-25
Device Publish Date2018-05-25

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