đź“‹ FDA Reference

bblcrystal neisseria haemophilus n h system

Becton Dickinson Microbiology Systems

Summary: The bblcrystal Neisseria Haemophilus NH System is a diagnostic tool used for identifying Neisseria and Haemophilus species. It is primarily used by microbiologists in laboratory settings.

FDA Clearance Information

Pathway 510K
Decision Date August 2, 1996
Product Code JST
Device Class Class 1
Evidence 419 studies

The bblcrystal Neisseria Haemophilus NH System was cleared through the FDA 510(k) pathway on August 2, 1996. Manufactured by Becton Dickinson Microbiology Systems, it is classified as a Class 1 device.

What It Is

The bblcrystal Neisseria Haemophilus NH System is a diagnostic device designed to identify Neisseria and Haemophilus species from clinical specimens. It utilizes biochemical reactions to differentiate these bacteria based on their metabolic characteristics. This system aids in the rapid and accurate identification of pathogens, which is crucial for effective patient management and treatment.

Clinical Applications

This device is commonly used in microbiology laboratories within hospitals and clinical settings. It assists in diagnosing infections caused by Neisseria and Haemophilus species, which can lead to conditions such as meningitis and respiratory infections. Clinicians and laboratory technicians use this system to ensure timely and appropriate antimicrobial therapy, particularly in pediatric and immunocompromised patient populations.

Indications for Use

The FDA indications for this device involve the identification of Neisseria and Haemophilus species from clinical samples. It is used to diagnose infections caused by these bacteria, aiding in the selection of appropriate treatment options.

Practical Considerations

The bblcrystal system is typically compatible with standard laboratory equipment and requires minimal training for use. It is important to follow the manufacturer's instructions for specimen preparation and handling to ensure accurate results.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

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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

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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

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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

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

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PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

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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

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PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

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PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

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PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

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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

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PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

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Frequently Asked Questions

What is bblcrystal Neisseria Haemophilus NH System used for?

It is used for the identification of Neisseria and Haemophilus species in clinical specimens.

What specialties typically use this device?

Microbiologists and laboratory technicians in clinical and hospital laboratories typically use this device.

What are the FDA-cleared indications?

The device is indicated for identifying Neisseria and Haemophilus species to aid in diagnosing related 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.

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