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Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-050
In Commercial Distribution
- M896AMS500350500 ()
- Haematological concentrate system preparation kit, platelet concentration
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
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area.
Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution
- W41020AU201S1969 ()
- Area/Surface Area: 50 Square centimeter
- Cultured skin autograft/xenograft
Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
MICRONICS, INC.
BT-101-025
In Commercial Distribution
- 00815312020000 ()
- 00815312020048 ()
BT-101-025
- ABO/Rh multiple blood grouping IVD, kit, agglutination
ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.
Lgc Clinical Diagnostics, Inc.
2020-0107
In Commercial Distribution
- 00816784020901 ()
2020-0107
- West Nile virus nucleic acid IVD, control
ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Lgc Clinical Diagnostics, Inc.
2000-0006
In Commercial Distribution
- 00816784020888 ()
2000-0006
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution
- 00816784020628 ()
- Total Volume: 20 Milliliter
2020-0105
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution
- 00816784020611 ()
- Total Volume: 5 Milliliter
2020-0104
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control