ACL TOP 770s 00000280017

GUDID 00195226000542

ACL TOP 770s

INSTRUMENTATION LABORATORY COMPANY

Coagulation analyser IVD, laboratory
Primary Device ID00195226000542
NIH Device Record Keyf492ec19-d3cb-434e-8667-0e0643c9daf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameACL TOP 770s
Version Model Number00000280017
Catalog Number00000280017
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

Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com
Phone800-678-0710
Emailtechsupport.na@werfen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195226000542 [Primary]

FDA Product Code

GKPInstrument, Coagulation, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-23
Device Publish Date2024-05-15

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

08430793242998 - HEMOSIL RIVAROXABAN CONTROLS2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial
08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
00195226001129 - HemosIL Chromogenic Factor IX2024-07-17 HemosIL Chromogenic Factor IX
00195226000528 - ACL TOP 7702024-05-23 ACL TOP 770
00195226000535 - ACL TOP 770 LAS2024-05-23 ACL TOP 770 LAS
00195226000542 - ACL TOP 770s2024-05-23ACL TOP 770s
00195226000542 - ACL TOP 770s2024-05-23 ACL TOP 770s
00195226000559 - ACL TOP 5702024-05-23 ACL TOP 570
00195226000566 - ACL TOP 3702024-05-23 ACL TOP 370

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