3m Igg Fastlyme(tm) Test
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K895713 FDA 510(k)
- FDA Product Code
- LSR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3830 FDA 510(k)
- Regulation Number
- 866.3830 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3M IGG FASTLYME TEST is a Borrelia serological reagent used for laboratory testing. It is a device that aids in the detection of antibodies to Borrelia, the bacterium that causes Lyme disease. This test falls under the device category of reagents used in microbiology laboratories.
The device is supplied as a laboratory test kit and is intended for single-use applications. It is not MRI compatible and requires standard laboratory storage conditions. The 3M IGG FASTLYME TEST has FDA 510(k) clearance with the product code LSR and is classified as a Class II device under regulation number 866.3830.
Frequently asked questions
What is the 3M IGG FASTLYME TEST used for?
The 3M IGG FASTLYME TEST is a Borrelia serological reagent used in laboratory testing to detect antibodies to Borrelia, the bacterium that causes Lyme disease. It is intended for use in microbiology laboratories.
How is the 3M IGG FASTLYME TEST supplied?
The device is supplied as a laboratory test kit and is intended for single-use applications. It requires standard laboratory storage conditions and is not MRI compatible.
What is the regulatory status of the 3M IGG FASTLYME TEST?
The 3M IGG FASTLYME TEST has FDA 510(k) clearance with the product code LSR and is classified as a Class II device under regulation number 866.3830. It was found to be substantially equivalent to other marketed devices.
Is the 3M IGG FASTLYME TEST reusable?
No, the 3M IGG FASTLYME TEST is intended for single-use applications only. It should not be reused for any purpose after initial use to ensure accurate test results and maintain safety standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K895713 FDA 510(k) - 3M IGG FASTLYME(TM) TEST | 3M Company, 3M IGG FASTLYME(TM) TEST (K895713) — FDA 510(k) | Innolitics, 3m Igg Fastlyme (tm) Test 510 (k) K895713 - FDA.report, PDF K895713 3M IGG FASTLYME(TM) TEST - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K895713 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K895713 24 fields · synced Sep 24, 2026