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haemophilus i d ii triplate
Remel
Summary: The Haemophilus i d ii Triplate by Remel is a diagnostic device used primarily in microbiology labs to identify Haemophilus species. It is utilized by clinical laboratory professionals for accurate bacterial identification.
FDA Clearance Information
Pathway
510K
Number
K840338 ↗
Decision Date
April 17, 1984
Product Code
JSI
Device Class
Class 1
Evidence
419 studies
The Haemophilus i d ii Triplate was cleared through the FDA 510(k) pathway on April 17, 1984. Manufactured by Remel, it is classified as a Class 1 device under product code JSI.
What It Is
The Haemophilus i d ii Triplate is a diagnostic tool designed to facilitate the identification of Haemophilus species in clinical specimens. It consists of a specialized agar medium that supports the growth of these bacteria, allowing for their differentiation based on specific growth requirements. This device is crucial for microbiologists in clinical laboratories to accurately diagnose infections caused by Haemophilus species, which can lead to conditions such as respiratory infections and meningitis.
Clinical Applications
This device is commonly used in hospital and reference laboratories where microbiological analysis is performed. It is particularly useful in diagnosing infections in patients with suspected Haemophilus-related diseases, such as respiratory tract infections or invasive diseases like meningitis. The Haemophilus i d ii Triplate is essential for infectious disease specialists and clinical microbiologists who require precise identification of bacterial pathogens to guide appropriate treatment strategies.
Indications for Use
The FDA indications for the Haemophilus i d ii Triplate involve its use in identifying and differentiating Haemophilus species in clinical samples. This is particularly important for patients suspected of having infections caused by these bacteria, enabling targeted antimicrobial therapy.
Practical Considerations
The Haemophilus i d ii Triplate is typically used in conjunction with other laboratory techniques for comprehensive bacterial identification. It is compatible with standard laboratory equipment, and users should ensure proper incubation conditions to achieve accurate results. No specific sizing is required, as it is designed for use with standard laboratory protocols.
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 Haemophilus i d ii Triplate used for?
It is used for identifying and differentiating Haemophilus species in clinical specimens.
What specialties typically use this device?
Clinical microbiologists and infectious disease specialists in hospital and reference laboratories.
What are the FDA-cleared indications?
For identifying and differentiating Haemophilus species in clinical samples to aid in diagnosing infections.
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.