STAT-Site Linearity Check

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name: STAT-Site Linearity Check FDA UDI
Generic Name: Beta-hydroxybutyrate IVD, calibrator FDA UDI
Device Name: The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. FDA UDI
Model / Reference: 303500 FDA UDI
Description: The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. FDA UDI

Identifiers

Catalog Number: 303500 FDA UDI
Primary DI / UDI-DI: 00657498000113 FDA UDI
FDA Product Code: JIN FDA UDI
GMDN Term: Beta-hydroxybutyrate IVD, calibrator 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

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Beta-hydroxybutyrate IVD, calibrator

STAT-Site Linearity Check by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-hydroxybutyrate IVD, calibrator.

Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
β-Hydroxybutyrate 21 Linearity Standards — DiaSys Diagnostic Systems GmbH · Class II
TDM/B-Hydroxybutyrate Linearity Standards — STANBIO LABORATORY, L.P. · 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: Stanbio Laboratory, L.p.

Sources (1)

FDA UDI c7da517e-cdbb-4cdb-8463-f762bc330b3b 36 fields · synced Jun 8, 2026