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haemophilus test medium agar
Remel
Summary: The haemophilus test medium agar is used for the cultivation and isolation of Haemophilus species, primarily in microbiology labs. It is utilized by clinical microbiologists to diagnose infections caused by Haemophilus influenzae.
FDA Clearance Information
Pathway
510K
Number
K892928 ↗
Decision Date
June 13, 1989
Product Code
JSO
Device Class
Class 2
Evidence
419 studies
The haemophilus test medium agar by Remel was cleared through the FDA 510k pathway on June 13, 1989. It is classified as a Class 2 device under product code JSO.
What It Is
The haemophilus test medium agar is a specialized culture medium designed to support the growth of Haemophilus species, which are fastidious organisms requiring specific nutrients. This medium typically contains factors like hemin and NAD to facilitate the growth of these bacteria. It is an essential tool in clinical microbiology for the identification and isolation of Haemophilus influenzae, a common cause of respiratory infections.
Clinical Applications
This medium is primarily used in clinical microbiology laboratories for the isolation and identification of Haemophilus species from clinical specimens such as sputum, blood, and cerebrospinal fluid. It is particularly useful in diagnosing respiratory tract infections, meningitis, and other systemic infections caused by Haemophilus influenzae. The device is commonly used in hospital laboratories, public health labs, and research settings.
Indications for Use
The haemophilus test medium agar is indicated for use in the cultivation and isolation of Haemophilus species. It is particularly useful for diagnosing infections in patients suspected of having diseases caused by Haemophilus influenzae, such as respiratory infections or meningitis.
Practical Considerations
The medium is typically available in pre-poured agar plates, which are ready to use. It is compatible with standard microbiological techniques and requires incubation under appropriate conditions to support bacterial growth. Clinicians should ensure proper storage conditions to maintain the medium's efficacy.
Related Literature
The linked study evaluated the antimicrobial activity of gatifloxacin against Haemophilus influenzae and Moraxella catarrhalis. It involved susceptibility testing and quality control guidelines, showing gatifloxacin as highly effective against H. influenzae. The study highlighted the importance of accurate susceptibility testing in guiding effective treatment, though it was limited to in vitro conditions and specific geographic regions.
Linked Studies (20)
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Clinical progress note: Haemophilus influenzae type b.
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is haemophilus test medium agar used for?
It is used for the cultivation and isolation of Haemophilus species, particularly Haemophilus influenzae, in clinical microbiology laboratories.
What specialties typically use this device?
Clinical microbiologists in hospital and public health laboratories commonly use this medium for diagnosing bacterial infections.
What are the FDA-cleared indications?
It is indicated for the cultivation and isolation of Haemophilus species, aiding in the diagnosis of infections caused by these bacteria.
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.