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The ZEUS IFA Epstein-Barr Virus Early Antigen (EBV-EA) IgG Test System is a sensitive and relatively rapid indirect fluorescent antibody (IFA) method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human sera. When performed according to instructions, the ZEUS IFA EBV-EA IgG Test System detects IgG antibodies to diffuse (D) and restricted (R) components of the EBV-EA complex. It is useful in providing information to support the diagnosis of infectious mononucleosis (IM). This device is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
FA9152
In Commercial Distribution
- 00845533001595 ()
FA9152
- Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution
- 04260160470587 ()
201001
- Coagulation analyser IVD, laboratory, semi-automated
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution
- 04260160470020 ()
200100-US
- Coagulation analyser IVD, laboratory, semi-automated
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution
- 00618474000008 ()
- Skin regeneration template, human-/animal-derived
Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly.
Shenzhen Konmed Technology Co., Ltd.
KM518
In Commercial Distribution
- 06970935830017 ()
- Perineal orifice incontinence-control electrical stimulation system
A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.
GERMAINE LABORATORIES, INC
77025
In Commercial Distribution
- 00695684770259 ()
- 00695684770251 ()
- Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias.
CARDIOCOMMAND, INC.
2A Patient Cable
In Commercial Distribution
- 00856233005073 ()
2010
- Temporary cardiac pacing/stimulation connection cable, reusable
Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes
THERADIAG SA
Connective 10
In Commercial Distribution
- 03760170782003 ()
MX 506
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4 ml vials.
STRECK, INC.
230304
In Commercial Distribution
- 10844509002205 ()
- 00844509002208 ()
- Total Volume: 4.0 Milliliter
230304
- Evacuated blood collection tube IVD, K3EDTA
A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials.
STRECK, INC.
213559
In Commercial Distribution
- 10844509000836 ()
- 00844509000839 ()
- Total Volume: 2.0 Milliliter
213559
- Evacuated blood collection tube IVD, K3EDTA