Essential Package Sample Collection Kit (usa)

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) FDA UDI
Generic Name: Venous blood collection kit IVD FDA UDI
Device Name: The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing. FDA UDI
Model / Reference: SCK10684 FDA UDI
Description: The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing. FDA UDI

Identifiers

Catalog Number: SCK10684 FDA UDI
Primary DI / UDI-DI: 05055273219951 FDA UDI
FDA Product Code: PQD FDA UDI
GMDN Term: Venous blood collection kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Venous blood collection kit IVD

Essential Package Sample Collection Kit (usa) by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Venous blood collection kit IVD.

EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60) — Randox Laboratories, Ltd. · Class II
EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) — Randox Laboratories, Ltd. · Class II

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: Randox Laboratories, Ltd.

Sources (1)

FDA UDI b990b7a1-a1fe-4a65-be48-652c828d0459 36 fields · synced Jun 8, 2026