HemosIL D-Dimer Controls 00022660030

GUDID 00195226000511

1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL 2. Level 2 D-D Control(Cat. No. 0022660032): 5 vials x 1 mL

INSTRUMENTATION LABORATORY COMPANY

D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control D-dimer IVD, control
Primary Device ID00195226000511
NIH Device Record Key72e7799c-6fab-4e67-bf6c-7695545e9abe
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL D-Dimer Controls
Version Model Number0022660030
Catalog Number00022660030
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

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

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100195226000511 [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 Date2021-08-23
Device Publish Date2021-08-15

On-Brand Devices [HemosIL D-Dimer Controls ]

08426950063179HemosIL D-Dimer Controls
001952260005111. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL 2. Level 2 D-D Control(Cat. No. 0022

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