Accuprobe Blastomyces Dermatit Cult Confirm Test
by Gen-Probe
510(k) K903201
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903201 | Date12 Sep 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MDC
- FDA applicant
- Gen-Probe, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3060
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Accuprobe Blastomyces Dermatitidis Culture Identification Test is a rapid DNA probe test designed for the identification of Blastomyces dermatitidis. It utilizes the technique of nucleic acid hybridization to confirm the presence of the organism from isolated cultures.
This device is classified as a DNA probe for Blastomyces dermatitidis and is regulated under FDA class 2. It received 510(k) clearance under K903201.
Other devices from Gen-Probe
Questions
AI-generated answers, 6 Oct 2026
What is the Accuprobe Blastomyces Dermatitidis Culture Identification Test used for?
The Accuprobe Blastomyces Dermatitidis Culture Identification Test is used to rapidly identify Blastomyces dermatitidis. It confirms the presence of the organism from isolated cultures using nucleic acid hybridization.
How does the Accuprobe Blastomyces Dermatitidis Culture Identification Test work?
This test utilizes nucleic acid hybridization, a technique that identifies specific DNA sequences, to confirm the presence of Blastomyces dermatitidis from isolated cultures.
What type of device is the Accuprobe Blastomyces Dermatitidis Culture Identification Test?
The Accuprobe Blastomyces Dermatitidis Culture Identification Test is classified as a DNA probe for Blastomyces dermatitidis.