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Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-056
In Commercial Distribution
- M896AMS500220560 ()
- Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-053
In Commercial Distribution
- M896AMS500220530 ()
- Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-050
In Commercial Distribution
- M896AMS500220500 ()
- Haematological concentrate system preparation kit, platelet concentration
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007514
In Commercial Distribution
- 10628451188268 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007521
In Commercial Distribution
- 10628451188251 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007538
In Commercial Distribution
- 10628451188244 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007569
In Commercial Distribution
- 10628451188237 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007552
In Commercial Distribution
- 10628451188220 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007545
In Commercial Distribution
- 10628451188213 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815211007507
In Commercial Distribution
- 10628451188169 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
The Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
In Commercial Distribution
- 00811877011125 ()
- HIV1/HIV2 antigen/antibody IVD, control
Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
In Commercial Distribution
- 00811877011101 ()
- HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution
- 00812747010217 ()
- Clinical laboratory information system application software
Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010200 ()
- Configurable electronic form web-based application software
Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010194 ()
- Blood bank information system application software
Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution
- 00812747010170 ()
- Blood bank information system application software
ElDorado Donor version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010149 ()
- Blood bank information system application software
ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution
- 00812747010132 ()
- Blood bank information system application software
McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution
- 00812747010118 ()
- Blood bank information system application software
InstaMatch version 1.X.X
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution
- 00812747010088 ()
- Blood bank information system application software
CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution
- 00812747010064 ()
- Clinical laboratory information system application software
NextGen version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010057 ()
- Blood bank information system application software
SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010033 ()
- Blood bank information system application software
BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution
- 00812747010019 ()
- Clinical laboratory information system application software
Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities:
• Positively identify transfusion recipients
• Match blood products to recipients
• Record recipient pertinent transfusion information
• Record recipient transfusion reactions and caregiver comments
CliniSys, Inc
3.0
Not in Commercial Distribution
- B236TRM3000 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
2024.1
In Commercial Distribution
- B236SQBB202410 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.3
In Commercial Distribution
- B236SQBB11030 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.2.3
Not in Commercial Distribution
- B236BB8230 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.1.3
Not in Commercial Distribution
- B236BB8130 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
8.0.1
Not in Commercial Distribution
- B236BB8010 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.2
Not in Commercial Distribution
- B236BB11020 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0.1
Not in Commercial Distribution
- B236BB11010 ()
- Blood bank information system application software
Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
11.0
Not in Commercial Distribution
- B236BB11000 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1.1
Not in Commercial Distribution
- B236BB10110 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.1
Not in Commercial Distribution
- B236BB10100 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0.1
Not in Commercial Distribution
- B236BB10010 ()
- Blood bank information system application software
Sunquest Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to:
• Record testing results of patient specimens and blood products either manually or through instrument interfaces.
• Maintain a historical record of the patient’s blood bank and transfusion related data.
• Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
• Store records of manufactured and blood product component preparation.
• Record the release of manufactured and blood products for infusion.
• Maintain manufactured and blood product inventory for lookback.
• Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
CliniSys, Inc
10.0
Not in Commercial Distribution
- B236BB10000 ()
- Blood bank information system application software
No Description
ESTAR TECHNOLOGIES LTD
1253VTSF10
Not in Commercial Distribution
- 07290015874229 ()
1253VTSF10
- Haematological concentrate system preparation kit, platelet concentration
No Description
ESTAR TECHNOLOGIES LTD
12991402GLA
In Commercial Distribution
- 07290015874120 ()
12991402GLA
- Haematological concentrate system preparation kit, platelet concentration
No Description
SCC SOFT COMPUTER
25.5.6.3
In Commercial Distribution
- 00810055813667 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.4.2
In Commercial Distribution
- 00810055813650 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution
- 00810055812257 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.6.1.2
In Commercial Distribution
- 00810055815647 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.20
In Commercial Distribution
- 00810055815302 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.4
In Commercial Distribution
- 00810055814503 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.5.1
In Commercial Distribution
- 00810055814152 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.19
In Commercial Distribution
- 00810055814145 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution
- 00810055812837 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution
- 00810055810727 ()
- Blood bank information system application software
Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution
- 06976052440092 ()
- Laboratory tubing welder