ACL TOP 300 CTS 00000280060

GUDID 08426950556916

ACL TOP 300 CTS

INSTRUMENTATION LABORATORY COMPANY

Coagulation analyser IVD, laboratory, automated
Primary Device ID08426950556916
NIH Device Record Keyff99ad58-605c-4dbb-831a-13769d0e6818
Commercial Distribution StatusIn Commercial Distribution
Brand NameACL TOP 300 CTS
Version Model Number00000280060
Catalog Number00000280060
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com
Phone18006780710
Emailtechsupport.na@werfen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950556916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKPINSTRUMENT, COAGULATION, AUTOMATED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-08
Device Publish Date2016-09-23

On-Brand Devices [ACL TOP 300 CTS]

08426950928027ACL TOP 300 CTS (Refurbished)
08426950556916ACL TOP 300 CTS

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