Biotek-Caribbean
DO Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Biosampler Ref K844615
What Biotek-Caribbean makes
Biotek-Caribbean manufactures the BIOSAMPLER, a device designed for collecting and preserving biological samples for laboratory analysis.
The BIOSAMPLER is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Biotek-Caribbean manufacture?
Biotek-Caribbean specializes in the BIOSAMPLER, a device intended for collecting and preserving biological samples. This device is designed to ensure sample integrity for subsequent laboratory analysis, making it useful in clinical, research, or diagnostic settings.
Where is Biotek-Caribbean based?
Biotek-Caribbean is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as it operates under U.S. medical device regulations.
How are Biotek-Caribbean’s devices classified under FDA regulations?
The BIOSAMPLER from Biotek-Caribbean is classified as a Class I medical device by the FDA. This classification is typically assigned to devices posing minimal risk to users, often due to their non-invasive nature or lack of significant energy output. Class I devices generally require less stringent regulatory controls, though compliance with good manufacturing practices (GMP) remains mandatory.
Are Biotek-Caribbean’s devices listed in any regulatory registries?
Yes, the BIOSAMPLER is included in the FDA’s 510(k) clearance registry. This registry tracks devices that have undergone a 510(k) premarket notification process, demonstrating that the manufacturer has shown the device is substantially equivalent to a legally marketed predicate device. Listing in this registry provides transparency about the device’s regulatory status.
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