BD CTGCTV2 443979

GUDID 00382904439798

BD CTGCTV2

BECTON, DICKINSON AND COMPANY

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated
Primary Device ID00382904439798
NIH Device Record Keybdba7331-2d5b-45d3-af0c-ae4a89fb077a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD CTGCTV2
Version Model Number443979
Catalog Number443979
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 Usefalse
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
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 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904439798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2022-06-16
Device Publish Date2022-06-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

60382904454755 - BD BACTEC™ 92402024-11-12 BD BACTEC™ 9240
60382904455707 - BD BACTEC™ 91202024-11-12 BD BACTEC™ 9120
00382904458003 - BD BACTEC™ 90502024-11-11 BD BACTEC™ 9050
00382904454166 - BD Onclarity HPV Self Collection Diluent Tube2024-11-11 BD Onclarity HPV Self Collection Diluent Tube
00382906639844 - Horizon2024-10-22 CD138 (MI15) BV421 ASR
00382906651204 - Horizon2024-10-22 CD197 (2-L1-A) APC-R700 ASR
00382906651297 - Horizon2024-10-22 CD194 (1G1) BV421 ASR
00382906651334 - Horizon2024-10-22 CD40 (5C3) BV605 ASR

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.