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STAT-Site M B-HB Strips

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
STAT-Site M B-HB Strips FDA UDI
Generic Name
Single-channel clinical chemistry analyser IVD, point-of-care FDA UDI
Device Name
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only. FDA UDI
Model / Reference
401010 FDA UDI
Description
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only. FDA UDI

Identifiers

Catalog Number
401010 FDA UDI
Primary DI / UDI-DI
00657498000090 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Single-channel clinical chemistry analyser IVD, point-of-care 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Single-channel clinical chemistry analyser IVD, point-of-care

STAT-Site M B-HB Strips by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-channel clinical chemistry analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI ff154bf4-9969-4185-8284-5c7db30c89b0 36 fields · synced Jun 1, 2026