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bilirubin standard-lyophilized
Dow Instruments & Reagents
Summary: The bilirubin standard-lyophilized by Dow Instruments & Reagents is a diagnostic tool used in clinical settings to measure bilirubin levels. It is FDA 510k cleared and supported by 15 studies, highlighting its role in conditions like neonatal hyperbilirubinemia.
FDA Clearance Information
Pathway
510K
Number
K830469 ↗
Decision Date
March 24, 1983
Product Code
JIT
Device Class
Class 2
Evidence
419 studies
The bilirubin standard-lyophilized was cleared via the FDA 510k pathway on March 24, 1983. It is manufactured by Dow Instruments & Reagents and classified as a Class 2 device.
What It Is
The bilirubin standard-lyophilized is a diagnostic reagent used to measure bilirubin levels in clinical samples. It is primarily used in the assessment of bilirubin-related conditions, such as jaundice, by providing a standardized measurement.
Clinical Applications
Commonly used in neonatal care to monitor and manage hyperbilirubinemia, the device is also applicable in evaluating liver function and diagnosing conditions associated with bilirubin metabolism.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2021 and 2025. These studies explore the role of bilirubin in different clinical contexts.
Reported Outcomes
Published studies report that bilirubin plays a significant role in conditions like neonatal hyperbilirubinemia and may have therapeutic potential in diseases such as Parkinson's. The evidence suggests bilirubin's involvement in metabolic processes and its potential neuroprotective effects.
Safety Profile
Reported complications include potential neurologic dysfunction in cases of severe hyperbilirubinemia. However, no specific adverse events related to the use of the bilirubin standard-lyophilized device itself were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically evaluating the bilirubin standard-lyophilized device. Further research is needed to fully understand its clinical impact and safety profile.
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 are the clinical indications for bilirubin standard-lyophilized?
The device is indicated for measuring bilirubin levels in conditions like neonatal hyperbilirubinemia and liver dysfunction.
What outcomes have been reported in clinical studies?
Studies report bilirubin's role in neonatal hyperbilirubinemia management and potential therapeutic effects in neurodegenerative diseases.
What complications have been reported?
Safety data indicate potential neurologic dysfunction in severe hyperbilirubinemia, but no specific device-related complications were noted.
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.