Perfect 3

FDA UDI

Class I (US FDA UDI)

by Biotest Medical Corporation

Identity

Trade Name: Perfect 3 FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Device Name: Perfect 3 Blood Glucose Test Strip 1.Part Number:BY8818G0NL4 2.Packing Materials No.:BL8818PEA FDA UDI
Model / Reference: 8818 FDA UDI
Description: Perfect 3 Blood Glucose Test Strip 1.Part Number:BY8818G0NL4 2.Packing Materials No.:BL8818PEA FDA UDI

Identifiers

Primary DI / UDI-DI: 04719871820261 FDA UDI
FDA Product Code: JJX FDA UDI
CGA FDA UDI
NBW FDA UDI
GMDN Term: Glucose IVD, kit, electrometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose IVD, kit, electrometry

Perfect 3 by Biotest Medical Corporation — Class I — 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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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

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 I	Pending data

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Manufacturer

Manufacturer: Biotest Medical Corporation

Sources (1)

FDA UDI 80d92d8c-e923-4a2d-b6be-827f772bc960 33 fields · synced Jun 8, 2026