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biotis haemophilus identification quad
Otisville Biotech
Summary: The biotis haemophilus identification quad is a diagnostic tool used to identify Haemophilus species. It is primarily used by microbiologists and laboratory technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K862387 ↗
Decision Date
July 3, 1986
Product Code
JSH
Device Class
Class 1
Evidence
419 studies
The biotis haemophilus identification quad was cleared through the FDA 510k pathway on July 3, 1986. Manufactured by Otisville Biotech, it is classified as a Class 1 device under product code JSH.
What It Is
The biotis haemophilus identification quad is a laboratory diagnostic device designed to identify various species of the Haemophilus genus. It works by utilizing specific biochemical reactions that are characteristic of these bacteria. This device aids in the rapid and accurate identification of Haemophilus species, which is crucial for diagnosing infections and guiding appropriate treatment.
Clinical Applications
This device is commonly used in microbiology laboratories within hospitals and clinics to identify Haemophilus infections, which can cause conditions like respiratory tract infections and meningitis. It is particularly useful in settings where rapid identification is critical for patient management, such as in pediatric and infectious disease specialties. The device is used on patient samples, such as sputum or blood cultures, to confirm the presence of Haemophilus species.
Indications for Use
The FDA indications suggest that this device is intended for identifying Haemophilus species in clinical specimens. It is used for patients suspected of having infections caused by these bacteria, enabling targeted antimicrobial therapy.
Practical Considerations
The biotis haemophilus identification quad is typically compatible with standard laboratory equipment and requires minimal training for use. It is important to follow proper specimen collection and handling procedures to ensure accurate results. The device is designed for ease of use, making it suitable for high-throughput laboratory environments.
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 biotis haemophilus identification quad used for?
It is used for identifying Haemophilus species in clinical specimens, aiding in the diagnosis of infections.
What specialties typically use this device?
Microbiologists and laboratory technicians in infectious disease and pediatric specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for identifying Haemophilus species in clinical specimens to assist 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.