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510(k) Data Aggregation
K Number
K071255Device Name
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
Manufacturer
HYPHEN BIOMED
Date Cleared
2007-09-07
(126 days)
Product Code
LCO
Regulation Number
864.7695Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
Device Description
The ZYMUTEST HIA is solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies. These antibodies are found in some patients undergoing heparin therapy.
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K Number
K050367Device Name
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
Manufacturer
HYPHEN BIOMED
Date Cleared
2006-05-24
(464 days)
Product Code
KFF
Regulation Number
864.7525Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma. Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.
Device Description
Not Found
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K Number
K050365Device Name
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
Manufacturer
HYPHEN BIOMED
Date Cleared
2005-12-27
(316 days)
Product Code
GGP
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method. Biophen Protein C 5 & 2.5 Kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Device Description
Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
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K Number
K051472Device Name
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
Manufacturer
HYPHEN BIOMED
Date Cleared
2005-12-23
(203 days)
Product Code
GGN, GGC, KFF
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biophen Low Molecular Weight Heparin (LMWH), Low Molecular Weight Heparin Low (LMWH Low) and Unfractionated Heparin (UFH) control are set of control plasmas for the quality control of Low Molecular weight Heparin(LMWH) and Unfractionated Heparin(UFH) measurements using anti Xa colorimetric assays (Biophen Heparin 3 & 6) . These control plasmas are within the usual therapeutic range recommended for the low molecular weight heparin (LMWH) and Unfractionated Heparin (UFH).
Biophen Heparin & Unfractionated heparin (UFH) Calibrators are set of calibration plasmas for the calibration of Low molecular weight heparin (LMWH) and Unfractionated heparin, using anti-Xa colorimetric assays.
Device Description
Biophen LMWH, LMWH Low and UFH Control Plasma is an in vitro diagnostic quality control intended for use with chromogenic assays to assess precision and accuracy at Heparin low and high levels (in the usual recommended therapeutic range).
Biophen Heparin Calibrator is a set of calibration plasmas for Heparin (UFH and LMWH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). Biophen Heparin Calibrator allows calibrating the assays of Low Molecular Weight Heparin (LMWH) using chromogenic anti-Xa methods. It can be also used for calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used. Biophen heparin is a chromogenic anti-Xa method developed for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve.
BIOPHEN UFH Calibrator is a set of calibration plasmas for Unfractionated Heparin (UFH) measurements, using anti-Xa colorimetric assays (BIOPHEN HEPARIN 3 and 6). BIOPHEN UFH Calibrator allows calibrating the measurements of Unfractionated Heparin (UFH) when the BIOPHEN Heparin kit is used.
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K Number
K043007Device Name
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
Manufacturer
HYPHEN BIOMED
Date Cleared
2005-11-07
(371 days)
Product Code
JBQ, 81J
Regulation Number
864.7060Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Device Description
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
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K Number
K043451Device Name
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
Manufacturer
HYPHEN BIOMED
Date Cleared
2005-03-17
(93 days)
Product Code
GGN
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
HYPHEN BIOMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay for the coagulation factors Antithrombin III and Protein C. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors. The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (APCR): when tested with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.
Device Description
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, lyophilised in the presence of additives and preservatives. It contains 12 vials of lyophilised reagent to be reconstituted with 1 ml distilled water.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
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