US IVD-Bruker Bacterial Test Standard, 5 Tubes

FDA UDI

Class II (US FDA UDI)

by Bruker Daltonik GmbH

Identity

Trade Name: US IVD-Bruker Bacterial Test Standard, 5 Tubes FDA UDI
Generic Name: Brain-responsive electrical stimulation system FDA UDI
Device Name: Bacterial Test Standard, 5 tubes. FDA UDI
Model / Reference: 8604530 FDA UDI
Description: Bacterial Test Standard, 5 tubes. FDA UDI

Identifiers

Catalog Number: 8604530 FDA UDI
Primary DI / UDI-DI: 04251204325642 FDA UDI
FDA Product Code: PEX FDA UDI
GMDN Term: Brain-responsive electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3361 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Brain-responsive electrical stimulation system

US IVD-Bruker Bacterial Test Standard, 5 Tubes by Bruker Daltonik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Bruker Daltonik GmbH

Sources (1)

FDA UDI 9e28ac8d-8b5b-4d90-aef0-311cd0200f4e 36 fields · synced Jun 6, 2026