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vis-cube hcg eia lyophilized jpl-044
Leeco Diagnostics
Summary: The vis-cube hcg eia lyophilized jpl-044 is a diagnostic device used for detecting human chorionic gonadotropin (hCG) levels. It is primarily utilized by laboratory technicians and clinicians in settings requiring hormonal assays.
FDA Clearance Information
Pathway
510K
Number
K870259 ↗
Decision Date
March 10, 1987
Product Code
JHI
Device Class
Class 2
Evidence
419 studies
The vis-cube hcg eia lyophilized jpl-044, manufactured by Leeco Diagnostics, was cleared via the FDA 510k pathway on March 10, 1987. It is a Class 2 device under product code JHI.
What It Is
The vis-cube hcg eia lyophilized jpl-044 is an enzyme immunoassay (EIA) designed to measure human chorionic gonadotropin (hCG) levels in biological samples. It utilizes a lyophilized format to ensure stability and ease of storage. This device is essential in clinical laboratories for pregnancy testing and monitoring certain medical conditions associated with hCG production.
Clinical Applications
This device is commonly used in clinical laboratories for pregnancy testing, as hCG is a key marker in early pregnancy detection. It is also utilized in oncology settings to monitor hCG levels in certain cancers, such as trophoblastic disease. The device is suitable for use in hospitals, diagnostic labs, and specialized clinics dealing with reproductive health.
Indications for Use
The device is indicated for the detection and quantification of hCG in patient samples. It is used for confirming pregnancy, diagnosing potential pregnancy-related complications, and monitoring hCG-secreting tumors.
Practical Considerations
The vis-cube hcg eia lyophilized jpl-044 is compatible with standard laboratory equipment used for enzyme immunoassays. It requires careful handling to maintain the integrity of the lyophilized components. Proper calibration and validation of results are essential for accurate diagnostics.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is vis-cube hcg eia lyophilized jpl-044 used for?
It is used for detecting and measuring hCG levels, primarily for pregnancy testing and monitoring certain cancers.
What specialties typically use this device?
This device is typically used by laboratory technicians and clinicians in reproductive health and oncology.
What are the FDA-cleared indications?
The device is cleared for detecting hCG in biological samples, useful in pregnancy confirmation and monitoring hCG-secreting tumors.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.