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haemophilus test medium broth
Regional Media Laboratories
Summary: The haemophilus test medium broth is used for susceptibility testing of Haemophilus influenzae. It is FDA 510k cleared and linked to studies evaluating its effectiveness in identifying resistant strains.
FDA Clearance Information
Pathway
510K
Number
K894848 ↗
Decision Date
September 6, 1989
Product Code
JSO
Device Class
Class 2
Evidence
419 studies
The haemophilus test medium broth was cleared through the FDA 510k pathway on September 6, 1989. It is manufactured by Regional Media Laboratories and classified as a Class 2 device.
What It Is
The haemophilus test medium broth is a culture medium designed for the growth and susceptibility testing of Haemophilus influenzae. It is used in clinical laboratories to determine antibiotic resistance patterns.
Clinical Applications
This device is commonly used in clinical microbiology labs for testing the susceptibility of Haemophilus influenzae to various antibiotics. It aids in the identification of resistant strains, which is crucial for effective treatment planning.
Evidence Summary
The literature includes three studies, ranging from 1997 to 2016, focusing on the efficacy of the haemophilus test medium broth in susceptibility testing. Study types include retrospective analyses and evaluations of testing methods.
Reported Outcomes
Published studies report that the haemophilus test medium broth is effective in identifying beta-lactamase-negative, ampicillin-resistant strains of Haemophilus influenzae. It has been compared favorably with other media in susceptibility testing.
Safety Profile
Reported complications include variability in resistance detection depending on the medium and test method used. No major safety concerns were highlighted in the studies provided.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in testing methods. Further research is needed to standardize susceptibility testing protocols and confirm findings across diverse clinical settings.
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 haemophilus test medium broth?
The haemophilus test medium broth is indicated for use in susceptibility testing of Haemophilus influenzae to determine antibiotic resistance.
What outcomes have been reported in clinical studies?
Studies have reported effective identification of resistant strains of Haemophilus influenzae, particularly beta-lactamase-negative, ampicillin-resistant strains.
What complications have been reported?
Safety data indicate variability in resistance detection based on the medium and test method, but no major safety issues were reported.
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.