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Precision Xtra

FDA UDI

Class I (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
Precision Xtra FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Device Name
Precision Xtra Blood ß-Ketone Test Strips FDA UDI
Model / Reference
70746 FDA UDI
Description
Precision Xtra Blood ß-Ketone Test Strips FDA UDI

Identifiers

Catalog Number
70746 FDA UDI
Primary DI / UDI-DI
00093815707462 FDA UDI
510(k) Number
K060768 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-useMultiple clinical chemistry analyte monitoring system IVD, point-of-care

A comprehensive medical device directory entry for the Precision Xtra Blood ß-Ketone Test Strips.

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, point-of-care.

Cleared under the same submission

K060768 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 2e49832e-5014-4e92-98da-5a5d25b4cf4c 37 fields · synced Jul 12, 2026