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BioFire® Blood Culture Identification 2 (BCID2) Panel

FDA UDI

Class II (US FDA UDI)

by BioFire Diagnostics, LLC

Identity

Trade Name
BioFire® Blood Culture Identification 2 (BCID2) Panel FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI
Device Name
IVD reagent kit containing 6 tests. FDA UDI
Model / Reference
RFIT-ASY-0148 FDA UDI
Description
IVD reagent kit containing 6 tests. FDA UDI

Identifiers

Primary DI / UDI-DI
00815381020345 FDA UDI
510(k) Number
K193519 FDA UDI
K243759 FDA UDI
FDA Product Code
PEN FDA UDI
PAM FDA UDI
PEO FDA UDI
GMDN Term
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3365 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-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

BioFire® Blood Culture Identification 2 (BCID2) Panel by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry.

Cleared under the same submission

K193519 also covers:

K243759 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioFire Diagnostics, LLC

Sources (1)

  • FDA UDI f5aa103b-aebf-41d3-ac9e-dec19f3c799e 34 fields · synced Jun 9, 2026