BioTel Care® Double Control Solution

FDA UDI

Class I (US FDA UDI)

by Telcare, Llc

Identity

Trade Name: BioTel Care® Double Control Solution FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. FDA UDI
Model / Reference: CS FDA UDI
Description: Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. FDA UDI

Identifiers

Catalog Number: TC0003 FDA UDI
Primary DI / UDI-DI: 00859519002056 FDA UDI
510(k) Number: K110571 FDA UDI
FDA Product Code: JJX FDA UDI
NBW FDA UDI
GMDN Term: Glucose IVD, control 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose IVD, control

BioTel Care® Double Control Solution by Telcare, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110571 also covers:

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: Telcare, Llc

Sources (1)

FDA UDI c8232364-f735-4768-8f9e-36a411da9492 37 fields · synced May 29, 2026