Identity
- Trade Name
- Drew Scientific FDA UDI
- Generic Name
- Total lipoprotein IVD, control FDA UDI
- Device Name
- EX-TROL Low (1 x 4.5mL) Control FDA UDI
- Model / Reference
- EXA-45L FDA UDI
- Description
- EX-TROL Low (1 x 4.5mL) Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020388 FDA UDI
- 510(k) Number
- K061511 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Total lipoprotein IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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: Total lipoprotein IVD, control
Drew Scientific by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total lipoprotein IVD, control.
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- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class II
Cleared under the same submission
K061511 also covers:
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 26b46116-bf9f-47fd-95ef-9d5dd83df362 36 fields · synced Jun 6, 2026