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BD MAX™ System

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD MAX™ System FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
Instrument Max Clinical FDA UDI
Model / Reference
441916 FDA UDI
Description
Instrument Max Clinical FDA UDI

Identifiers

Catalog Number
441916 FDA UDI
Primary DI / UDI-DI
00382904419165 FDA UDI
FDA Product Code
OOI FDA UDI
OZN FDA UDI
NJR FDA UDI
NQX FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3130 FDA UDI
866.3740 FDA UDI
866.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 72.4 Centimeter FDA UDI
Width — 94 Centimeter FDA UDI
Depth — 75.4 Centimeter FDA UDI

Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory

BD MAX™ System by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermal cycler nucleic acid amplification analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI ab549f46-3096-474b-9033-a67fd6756c50 37 fields · synced May 30, 2026