Dna-Reagents, Chlamydia
DNA reagents for Chlamydia are nucleic acid-based diagnostic reagents used to detect Chlamydia trachomatis and related species in clinical specimens through molecular methods such as PCR, widely used for diagnosing chlamydial infections including sexually transmitted diseases and respiratory infections. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSK, regulated under 21 CFR 866.3120, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LSK
- Device Class
- FDA class 1
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | May 28, 2010 | Substantially Equivalent | Abbott Molecular, Inc. |
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | Sep 25, 2001 | Substantially Equivalent | Digene Corp. |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | Sep 24, 2001 | Substantially Equivalent | Digene Corp. |
| K990023 | HYBRID CAPTURE II CT-ID TEST | Oct 25, 1999 | Substantially Equivalent | Digene Corp. |
| K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | Apr 06, 1994 | Substantially Equivalent | Gen-Probe, Inc. |
| K920378 | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS | Apr 29, 1992 | Substantially Equivalent | Gen-Probe, Inc. |
| K874878 | GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS | Dec 29, 1987 | Substantially Equivalent | Gen-Probe, Inc. |
| K871878 | RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS | Oct 28, 1987 | Substantially Equivalent | Gen-Probe, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.