FDA.report

GEM Check Coag Control-Abnormal for ACT

Primary DI
08426950088653
Brand
GEM Check Coag Control-Abnormal for ACT
Company
INSTRUMENTATION LABORATORY COMPANY
Model
06260060300
Catalog number
06260060300
Device description
GEM Check Coag Control-Abnormal for ACT
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
GGNPLASMA, COAGULATION CONTROL

Product Code Classifications

CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950088653PrimaryGS10
18426950088650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950088653084269500886538426950088653
1842695008865018426950088650

GMDN Terms

TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling

TypeLowHighCondition
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
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815696021327George King Heparin Control Plasma GEORGE KING BIO-MEDICAL, INCGGN2025-07-11
08718734962779CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962786CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962793CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962809CueSee® CoagEurotrol B.V.GGN2025-04-08
08718734962816CueSee® CoagEurotrol B.V.GGN2025-04-08
09360136000055Xprecia™ Systems PT ControlsUNIVERSAL BIOSENSORS PTY LTDGGN2024-08-27
08430793242998HEMOSIL RIVAROXABAN CONTROLSINSTRUMENTATION LABORATORY COMPANYGGN2024-07-22
00630414229522INNOVANCE Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229546INNOVANCE Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229515INNOVANCE Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00630414229539INNOVANCE Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019463Dade Ci-Trol Coagulation Control Level 2Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019456Dade Ci-Trol Coagulation Control Level 3Siemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768019005ProC Control PlasmaSiemens Healthcare Diagnostics Products GmbHGGN2024-03-25
00842768018909Control Plasma N Siemens Healthcare Diagnostics Products GmbHGGN2024-02-19
00850053916212IDG/SanzayIDG/SANZAY CorporationGGN2024-01-12
00850053916229IDG/SanzayIDG/SANZAY CorporationGGN2024-01-12
00763000561826NAMEDTRONIC, INC.GGN2023-03-27
00815696021297George King Pooled Normal PlasmaGEORGE KING BIO-MEDICAL, INCGGN2022-03-03
00815696021303George King Single Donor Normal PlasmaGEORGE KING BIO-MEDICAL, INCGGN2022-03-03
00711234170345directCHECK ACT+ Whole Blood Control Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.GGN2022-01-21
00711234170352directCHECK ACT+ Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.GGN2022-01-21
00711234170369directCHECK ACT-LR Whole Blood Controls, Level 1ACCRIVA DIAGNOSTICS HOLDINGS, INC.GGN2022-01-21
00711234170376directCHECK ACT-LR Whole Blood Control, Level 2ACCRIVA DIAGNOSTICS HOLDINGS, INC.GGN2022-01-21
00815696021280George King Coumadin® PlasmaGEORGE KING BIO-MEDICAL, INCGGN2022-01-20
00763000014803N/AMEDTRONIC, INC.GGN2021-11-12
00195226000511HemosIL D-Dimer Controls INSTRUMENTATION LABORATORY COMPANYGGN2021-08-15
00812747018510Haemonetics TEG 6sHAEMONETICS CORPORATIONGGN2021-06-18
00812747018497Haemonetics TEG 6sHAEMONETICS CORPORATIONGGN2021-06-17