Coamatic LR Antithrombin 82 2957 63

GUDID 08426950088936

Coamatic LR Antithrombin

INSTRUMENTATION LABORATORY COMPANY

Antithrombin III (ATIII) IVD, kit, chromogenic
Primary Device ID08426950088936
NIH Device Record Key9853d384-4626-40d9-b1bf-65b18f914663
Commercial Distribution Discontinuation2020-02-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCoamatic LR Antithrombin
Version Model Number82 2957 63
Catalog Number82 2957 63
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 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

Phone800-678-0710
Emailtechsupport@ilww.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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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 reagents and calibrator 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
GS108426950088936 [Primary]

FDA Product Code

JBQANTITHROMBIN III QUANTITATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-03
Device Publish Date2016-09-23

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