← Back to catalogue

TDM/B-Hydroxybutyrate Linearity Standards

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
TDM/B-Hydroxybutyrate Linearity Standards FDA UDI
Generic Name
Beta-hydroxybutyrate IVD, calibrator FDA UDI
Device Name
For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, Theophylline, and ß-Hydroxybutyrate. FDA UDI
Model / Reference
2450-604 FDA UDI
Description
For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, Theophylline, and ß-Hydroxybutyrate. FDA UDI

Identifiers

Catalog Number
2450-604 FDA UDI
Primary DI / UDI-DI
00657498000557 FDA UDI
FDA Product Code
DKB FDA UDI
GMDN Term
Beta-hydroxybutyrate IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 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: Beta-hydroxybutyrate IVD, calibrator

TDM/B-Hydroxybutyrate Linearity Standards by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-hydroxybutyrate IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI a7ecbe3d-540e-4104-ae11-fac7153ee4f9 36 fields · synced Jun 8, 2026