GHT Test Strip

FDA UDI

Class II (US FDA UDI)

by Genesis Health Technologies

Identity

Trade Name: GHT Test Strip FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Model / Reference: TD-4123 FDA UDI

Identifiers

Primary DI / UDI-DI: 00713757464802 FDA UDI
510(k) Number: K121224 FDA UDI
FDA Product Code: LFR 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

Yes

FDA UDI

Category: Glucose IVD, kit, electrometry

GHT Test Strip by Genesis Health Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
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Cleared under the same submission

K121224 also covers:

GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM — Genesis Health Technologies

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: Genesis Health Technologies

Sources (1)

FDA UDI 8e9a9850-f0df-418d-828a-378a76963633 33 fields · synced May 30, 2026