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Del(7q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH025
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe
- Myelodysplastic syndrome (MDS) IVD, probe
Del(5q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH024
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe
- Myelodysplastic syndrome (MDS) IVD, probe
CBFbeta (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH022
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe
Del(20q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH020
- Myelodysplastic syndrome (MDS) IVD, probe
P53 (TP53) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH017
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe
- Myelodysplastic syndrome (MDS) IVD, probe
MLL (KMT2A) Breakapart FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH013
- Acute myeloid leukaemia (AML) genetic mutation IVD, probe
- Myelodysplastic syndrome (MDS) IVD, probe
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
STRAIGHT SMILE LLC
KIT
- Dental impression material kit, single-use
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
- MRI image interpretive software
Minne Ties Sterile Supplemental Thin Two Pack: Two Supplemental Thin Sutures of the Same Size (.7 mm/21 ga)
Invisian Medical, LLC
MT-1002
MT-1002
- Temporary maxillomandibular fixation set