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Sign in to claim this brandBlackfly Investments, LLC
US
Last updated May 23, 2026
What Blackfly Investments, LLC makes
The company produces in vitro diagnostic (IVD) specimen collection devices, including dried blood spot collection kits and cards, blood collection paper, urine and faecal specimen collection kits for home use, and single-use swabs for oral, upper respiratory, and sexually transmitted infection (STI) testing. It also supplies general-purpose absorbent swabs and applicators designed for clinical and diagnostic applications.
All listed devices fall under Class I regulatory classification in the US and are registered in the FDA Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable US regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Blackfly Investments, LLC manufacture?
Blackfly Investments, LLC specializes in in vitro diagnostic (IVD) specimen collection devices. These include dried blood spot collection kits and cards, blood collection paper, urine and faecal specimen collection kits designed for home use, and single-use swabs for oral, upper respiratory, and sexually transmitted infection (STI) testing. The company also supplies general-purpose absorbent swabs and applicators for clinical and diagnostic purposes.
Where is Blackfly Investments, LLC based?
Blackfly Investments, LLC is based in the United States. The company operates within the country and adheres to applicable US regulatory requirements for medical devices.
Which regulatory registries list Blackfly Investments, LLC’s devices?
Blackfly Investments, LLC’s devices are registered in the FDA Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US market.
How are Blackfly Investments, LLC’s devices classified under US regulations?
All of Blackfly Investments, LLC’s listed devices fall under Class I regulatory classification in the US. Class I devices are generally considered to pose the lowest risk and often require less regulatory oversight, though they must still comply with applicable manufacturing and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 069497839
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Molecular Testing Labs | Dried Blood Spot, Urine, and Swab Collection Kit | FDA UDI | N/A | Active |
| Molecular Testing Labs | 1.0 | FDA UDI | N/A | Active |
| CVS Health At Home | Lyme Disease Collection Kit | FDA UDI | N/A | Active |
| CVS Health At Home | STI collection kit | FDA UDI | Class I | Active |
| Molecular Testing Labs | Dried Blood Spot and Neat Urine Collection Kit | FDA UDI | N/A | Active |
| Molecular Testing Labs | 1.0 | FDA UDI | N/A | Active |
| Molecular Testing Labs | Swab Collection Kit | FDA UDI | N/A | Active |
| CVS Health At Home | Thyroid collection kit | FDA UDI | N/A | Active |
| CVS Health At Home | Food Sensitivity collection | FDA UDI | N/A | Unknown |
| Molecular Testing Labs | Dried Blood Spot and Swab Collection Kit | FDA UDI | N/A | Active |
| CVS Health At Home | Vitamin D collection kit | FDA UDI | N/A | Active |
| Molecular Testing Labs | 1.0 | FDA UDI | N/A | Active |
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