Identity
- Trade Name
- Molecular Testing Labs FDA UDI
- Generic Name
- Dried blood spot collection kit IVD FDA UDI
- Device Name
- Dried Blood Spot and Urine Collection Kit FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Dried Blood Spot and Urine Collection Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008357878 FDA UDI
- GMDN Term
- Dried blood spot collection kit IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine specimen collection kit IVDDried blood spot collection kit IVD
Molecular Testing Labs by Blackfly Investments, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Molecular Testing Labs — Blackfly Investments, LLC
- CVS Health At Home — Blackfly Investments, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Blackfly Investments, LLC
Sources (1)
- FDA UDI c8ec800c-4ded-4374-b88e-b1f26ac007ed 33 fields · synced Jun 6, 2026