UltraTRAK Complete 50 Test Strips

FDA UDI

Class II (US FDA UDI)

by Vertex Diagnostics Llc

Identity

Trade Name: UltraTRAK Complete 50 Test Strips FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Model / Reference: TD-4231 FDA UDI

Identifiers

Primary DI / UDI-DI: 00385930000017 FDA UDI
510(k) Number: K063212 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Glucose IVD, kit, electrometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose IVD, kit, electrometry

UltraTRAK Complete 50 Test Strips by Vertex Diagnostics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose IVD, kit, electrometry.

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VivaGuard Ino — Able Diagnostics Inc · Class II
Easy Talk Blood Glucose Testing Strips 25ct — HOME AIDE DIAGNOSTICS, INC. · Class II
FORA — FORA CARE INC. · Class II
OneTouch Ultra — Lifescan, Inc. · Class II
EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II

Cleared under the same submission

K063212 also covers:

Rapid Response — BTNX Inc
Rapid Response — BTNX Inc
Rapid Response — BTNX Inc
Rapid Response — BTNX Inc
Rapid Response — BTNX Inc
Rapid Response — BTNX Inc
UltraTRAK TM Complete Blood Glucose Monitoring System — VERTEX DIAGNOSTICS LLC

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: Vertex Diagnostics Llc

Sources (1)

FDA UDI 3736450e-b29f-4a1b-9a0d-509c88fd43fc 33 fields · synced Jun 8, 2026