FDA.reportPublic FDA data

HemosIL AcuStar

Primary DI
08426950498001
Brand
HemosIL AcuStar
Company
INSTRUMENTATION LABORATORY COMPANY
Model
0009801000
Catalog number
0009801000
Device description
ACL AcuStar
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950498001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950498001084269504980018426950498001

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08430793242998HEMOSIL RIVAROXABAN CONTROLS0020015500000200155002024-07-22
08430793243001HEMOSIL RIVAROXABAN CALIBRATORS0020015400000200154002024-07-22
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
00195226000566ACL TOP 37000000280067000002800672024-05-15
00195226000641GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests)000774300102023-10-03
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
00195226000702GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests)000774450102023-10-02
00195226000719GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests)000774450102023-10-02
00195226000726GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests)000773600082023-10-02
00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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Primary DI, Brand, Company table
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04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
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