HemosIL FII & FV DNA Control 00020003500

GUDID 08426950453086

HemosIL FII & FV DNA Control

INSTRUMENTATION LABORATORY COMPANY

Inherited thrombophilia IVD, control
Primary Device ID08426950453086
NIH Device Record Keye95a0faa-3ecd-4896-9581-b7ce9de522ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL FII & FV DNA Control
Version Model Number00020003500
Catalog Number00020003500
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count3
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

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
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950453086 [Primary]
GS118426950453083 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZBQuality control material, genetics, dna

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

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 770s2024-05-23 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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