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Auvon

FDA UDI

Class II (US FDA UDI)

by Shenzhen Yuwen E-Commerce Co., Ltd.

Identity

Trade Name
AUVON FDA UDI
Generic Name
Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI
Device Name
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. FDA UDI
Model / Reference
TS1111011 FDA UDI
Description
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. FDA UDI

Identifiers

Primary DI / UDI-DI
06971292001140 FDA UDI
FDA Product Code
FMK FDA UDI
GMDN Term
Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose IVD, kit, enzyme spectrophotometry, rapid

Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose IVD, kit, enzyme spectrophotometry, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Yuwen E-Commerce Co., Ltd.

Sources (1)

  • FDA UDI 98b78236-3691-487d-b326-bc85b025ba69 33 fields · synced May 30, 2026