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ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0092
In Commercial Distribution
- 00816784020468 ()
- Total Volume: 42 Milliliter
2015-0092
- Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0090
In Commercial Distribution
- 00816784020451 ()
2015-0090
- Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 145 CMV IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0087
In Commercial Distribution
- 00816784020437 ()
2015-0087
- Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0066
In Commercial Distribution
- 00816784020260 ()
2015-0066
- HIV1 antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0065
In Commercial Distribution
- 00816784020253 ()
2015-0065
- HIV1 antigen IVD, control
ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2010-0015
In Commercial Distribution
- 00816784020222 ()
- Total Volume: 42 Milliliter
2010-0015
- Negative control immunoglobulin IVD
ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2010-0013
In Commercial Distribution
- 00816784020215 ()
- Total Volume: 5 Milliliter
2010-0013
- Negative control immunoglobulin IVD
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution
- 00816784020123 ()
2000-0032
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution
- 00816784020062 ()
2000-0018
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution
- 00816784020055 ()
2000-0010
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution
- 00816784020048 ()
2000-0008
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution
- 00816784020031 ()
2000-0002
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution
- 00816784020024 ()
2000-0001
- Multiple blood-borne virus antigen/antibody IVD, control
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution
- B73810071 ()
- Haematological concentrate system
No Description
Luvo Medical Technologies Inc
WORLDPRP
In Commercial Distribution
- 00754016214127 ()
- 10754016214124 ()
- Haematological concentrate system preparation kit, platelet concentration
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution
- 03665324000050 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution
- 03665324000036 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution
- 03665324000005 ()
- Blood bank information system
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution
- M5264C23041 ()
- M5264C23040 ()
- M5264C23043 ()
4C2304
- Blood transfer set
Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
Nuo Therapeutics, Inc.
AGWR-04
In Commercial Distribution
- 10852714003153 ()
- Wound dressing kit, medicated
Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-08
In Commercial Distribution
- 10852714003146 ()
- Wound dressing kit, medicated
Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-05
In Commercial Distribution
- 10852714003139 ()
- Wound dressing kit, medicated
Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-01
In Commercial Distribution
- 10852714003122 ()
- Wound dressing kit, medicated
Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution
- 10852714003108 ()
- Wound dressing kit, medicated
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution
- 20852282007147 ()
- 10852282007140 ()
- 00852282007143 ()
7201-50
- Medical product temperature point indicator, thermochemical
The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small
sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is
converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and
preserve platelets. The 18 mL SELPHYL® System is available as a single pack (item number 440910) or as a multipack of 10
each individually packaged kits (item number 440910-10). The 18 mL SELPHYL® System contains 2 blood collection tubes with
yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 2 PRFM
tubes containing calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™
access device, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BD
Vacutainer® Blood transfer device.
Factor Medical, Inc.
PRFM
In Commercial Distribution
- 30851802007107 ()
- 10851802007103 ()
- 10851802007035 ()
- Total Volume: 18 Milliliter
440910
- Haematological concentrate system preparation kit, platelet concentration
The SELPHYL® System is designed for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small
sample of blood at the patient point of care. SELPHYL ® removes contaminating red blood cells and white blood cells. PRP is
converted to Platelet-rich Fibrin Matrix (PRFM) through a controlled process, creating a scaffold that serves to protect and
preserve platelets. The 9 mL SELPHYL® System is available as a single pack (item number 420910) or as a multipack of 10
individually packaged kits (item number 420910-10). The 9 mL SELPHYL® System contains 1 blood collection tubes with yellow
stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube
containing Calcium chloride solution with red stopper, 1 latex free disposable tourniquet, 1 BD Vacutainer® Luer-Lok™ access
device, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, and 1 BD Vacutainer®
Blood transfer device.
Factor Medical, Inc.
PRFM
In Commercial Distribution
- 30851802007091 ()
- 10851802007097 ()
- 10851802007004 ()
- Total Volume: 9 Milliliter
420910
- Haematological concentrate system preparation kit, platelet concentration
No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution
- 10850685007002 ()
75007504
- Cell washer IVD
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
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution
- 00817955020010 ()
- Blood bank information system application software
CryoStore 50 EVA Freezing Bag, 10-30ml, "M3" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution
- 20816203024316 ()
- 10816203024319 ()
- 00816203024312 ()
CS50M3
- Blood/tissue storage/culture container
CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS30M9
In Commercial Distribution
- 20816203024309 ()
- 10816203024302 ()
CS30M9
- Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55-100ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution
- 20816203024286 ()
- 10816203024289 ()
- 00816203024282 ()
CS500
- Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250
In Commercial Distribution
- 20816203024255 ()
- 10816203024258 ()
- 00816203024251 ()
CS250
- Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag, 10-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution
- 20816203024248 ()
- 10816203024241 ()
- 00816203024244 ()
CS50N
- Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag, 10-30ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50
In Commercial Distribution
- 20816203024231 ()
- 10816203024234 ()
- 00816203024237 ()
CS50
- Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set, 8" donor tube
ORIGEN BIOMEDICAL, INC.
CS25XN
In Commercial Distribution
- 20816203024224 ()
- 10816203024227 ()
- 00816203024220 ()
CS25XN
- Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution
- 20816203024217 ()
- 10816203024210 ()
- 00816203024213 ()
CS25N
- Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25F
In Commercial Distribution
- 20816203024200 ()
- 10816203024203 ()
- 00816203024206 ()
CS25F
- Blood/tissue storage/culture container
CryoStore 28 EVA Freezing Bag, 10-25ml, "V" Tube Set
ORIGEN BIOMEDICAL, INC.
CS28V
In Commercial Distribution
- 20816203024064 ()
- 10816203024067 ()
- 00816203024060 ()
CS28V
- Blood/tissue storage/culture container