HEMOSIL RIVAROXABAN CONTROLS 00020015500

GUDID 08430793242998

1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vials

INSTRUMENTATION LABORATORY COMPANY

Coagulation factor Xa inhibitor IVD, control
Primary Device ID08430793242998
NIH Device Record Keyd791a557-6eed-4470-81b0-b99e823c75de
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEMOSIL RIVAROXABAN CONTROLS
Version Model Number0020015500
Catalog Number00020015500
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com
Phone8006780710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108430793242998 [Primary]

FDA Product Code

GGNPlasma, Coagulation Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

08430793242998 - HEMOSIL RIVAROXABAN CONTROLS2024-07-301. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vials
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 770s2024-05-23 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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