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BioCode Respiratory Pathogen Panel

FDA UDI

Class II (US FDA UDI)

by Applied BioCode, Inc.

Identity

Trade Name
BioCode Respiratory Pathogen Panel FDA UDI
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, control FDA UDI
Device Name
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. FDA UDI
Model / Reference
01 FDA UDI
Description
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. FDA UDI

Identifiers

Catalog Number
63-R0001 FDA UDI
Primary DI / UDI-DI
00851034007073 FDA UDI
510(k) Number
K192485 FDA UDI
FDA Product Code
NSU FDA UDI
OZZ FDA UDI
OZY FDA UDI
OZX FDA UDI
OTG FDA UDI
OOU FDA UDI
OEM FDA UDI
OEP FDA UDI
OZE FDA UDI
OCC FDA UDI
GMDN Term
Multiple-type respiratory pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3980 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

Yes

FDA UDI

Category: Multiple-type respiratory pathogen nucleic acid IVD, control

BioCode Respiratory Pathogen Panel by Applied BioCode, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type respiratory pathogen nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied BioCode, Inc.

Sources (1)

  • FDA UDI 86169df7-c0b5-496c-8036-508b9418e7f5 37 fields · synced May 30, 2026