FDA.report

HemosIL RecombiPlasTin 2G (8 mL)

Primary DI
08426950453079
Brand
HemosIL RecombiPlasTin 2G (8 mL)
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00020002950
Catalog number
00020002950
Device description
HemosIL RecombiPlasTin 2G (8 mL)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GJSTEST, TIME, PROTHROMBIN

Product Code Classifications

CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950453079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950453079084269504530798426950453079

GMDN Terms

TermDefinition
Prothrombin time (PT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Unopened reagents are stable until the expiration date shown on the vial, when stored at 2-8°C
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags

DUNS number
557223252
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08430793242998HEMOSIL RIVAROXABAN CONTROLS0020015500000200155002024-07-22
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00195226001129HemosIL Chromogenic Factor IX002001290000200129002024-07-09
00195226000528ACL TOP 77000000280057000002800572024-05-15
00195226000535ACL TOP 770 LAS00000280037000002800372024-05-15
00195226000542ACL TOP 770s00000280017000002800172024-05-15
00195226000559ACL TOP 57000000280047000002800472024-05-15
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00195226000627GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)000774450102023-10-02
00195226000634GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)000774450102023-10-02
00195226000658GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)000774150102023-10-02
00195226000665GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)000774075102023-10-02
00195226000672GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)000773600112023-10-02
00195226000689GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)000774450112023-10-02
00195226000696GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)000774450102023-10-02
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00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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