HemosIL Liquid Antithrombin 00020300440

GUDID 00195226000061

HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410) 2. 4 x 2 mL Chromogenic substrate (0020300420)

INSTRUMENTATION LABORATORY COMPANY

Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic

Primary Device ID	00195226000061
NIH Device Record Key	7fa22b7a-37c9-4f5f-9ef9-680a394f4a8a
Commercial Distribution Status	In Commercial Distribution
Brand Name	HemosIL Liquid Antithrombin
Version Model Number	0020300440
Catalog Number	00020300440
Company DUNS	557223252
Company Name	INSTRUMENTATION LABORATORY COMPANY
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@ilww.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com
Phone	1-800-678-0710
Email	techsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195226000061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K062431

FDA Product Code

JBQ	Antithrombin Iii Quantitation

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-08
Device Publish Date	2021-01-29

On-Brand Devices [HemosIL Liquid Antithrombin]

00195226000061	HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410) 2. 4 x 2 mL Chromogenic
08426950440802	HemosIL Liquid Antithrombin (2 mL)
08426950056003	HemosIL Liquid Antithrombin
08426950358701	HemosIL Liquid Antithrombin (4.5 mL)