HemosIL D-Dimer HS 500 00020500100

GUDID 08426950485605

HemosIL D-Dimer HS 500

INSTRUMENTATION LABORATORY COMPANY

D-dimer IVD, kit, agglutination
Primary Device ID08426950485605
NIH Device Record Key1c777e49-55cb-40bb-8526-576ff6fab533
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemosIL D-Dimer HS 500
Version Model Number00020500100
Catalog Number00020500100
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
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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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
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.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950485605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-08
Device Publish Date2016-09-23

On-Brand Devices [HemosIL D-Dimer HS 500]

08426951391615HemosIL D-Dimer HS 500 (XL)
08426950485605HemosIL D-Dimer HS 500

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