HemosIL Silica Clotting Time 00020004800

GUDID 08426950433491

HemosIL Silica Clotting Time

INSTRUMENTATION LABORATORY COMPANY

Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting
Primary Device ID08426950433491
NIH Device Record Keybe5dbdbb-d3a6-4b67-93fb-0dbfae68a0e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL Silica Clotting Time
Version Model Number00020004800
Catalog Number00020004800
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

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened reagents 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
GS108426950433491 [Primary]

FDA Product Code

GFOACTIVATED PARTIAL THROMBOPLASTIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-07-09
Device Publish Date2016-09-23

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