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BD MAX™ Enteric Bacterial Panel

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD MAX™ Enteric Bacterial Panel FDA UDI
Generic Name
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Kit BD MAX Enteric Bacterial Panel FDA UDI
Model / Reference
442963 FDA UDI
Description
Kit BD MAX Enteric Bacterial Panel FDA UDI

Identifiers

Catalog Number
442963 FDA UDI
Primary DI / UDI-DI
00382904429638 FDA UDI
510(k) Number
K214122 FDA UDI
FDA Product Code
PCH FDA UDI
OOI FDA UDI
PCI FDA UDI
GMDN Term
Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3990 FDA UDI
862.2570 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Similar devices

Also classified as Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K214122 also covers:

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 fbf614f6-b0cc-48a2-b28b-0ae298b0cb1f 37 fields · synced May 30, 2026