BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit (UDI SCK10796)
Manufactured by RANDOX LABORATORIES LIMITED
Device Regulatory Overview
The BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit (Model/Catalog Number: SCK10796) is a medical device manufactured by RANDOX LABORATORIES LIMITED. This product is indexed under FDA Product Code / Category Classification PQD within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SCK10796
- Product Code / EMDN
- PQD
- Device Name
- The Baseline Self-Draw (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemicallaboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or maybe collected under the guidance of a medical professional.
- Database Sync Date
- 2026-08-09 09:39:53
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit?
The registered manufacturer of record for BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit is RANDOX LABORATORIES LIMITED.
What is the Primary UDI-DI identifier for BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SCK10796.
What classification code is assigned to this device?
This device is registered under product classification code PQD.
Similar Classification Devices (PQD)
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