Oracle

FDA UDI

Class II (US FDA UDI)

by Biotest Medical Corporation

Identity

Trade Name: Oracle FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: Oracle Control Solution - Medium(BYGOD21BT) FDA UDI
Model / Reference: GOD21/BLM001ROA FDA UDI
Description: Oracle Control Solution - Medium(BYGOD21BT) FDA UDI

Identifiers

Primary DI / UDI-DI: 04719871820278 FDA UDI
FDA Product Code: NBW FDA UDI
JJX FDA UDI
CGA FDA UDI
GMDN Term: Glucose IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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, control

Oracle by Biotest Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose IVD, control.

WowGoHealth Control Solution - GSH-BGM902 - Level 1 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class I
OneTouch Ultra Plus — Lifescan Europe · Class II
TRUE METRIX — TRIVIDIA HEALTH, INC. · Class I
Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd. · Class I
TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
Assure® Prism Control Solution — ARKRAY USA, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biotest Medical Corporation

Sources (1)

FDA UDI 0ecc8c69-a9ec-48d2-bf84-fe0e08c27287 34 fields · synced Jun 8, 2026