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Rapidec® Carba Np

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
RAPIDEC® CARBA NP FDA UDI
Generic Name
Multiple bacteria carbapenemase production IVD, kit, chromogenic FDA UDI
Device Name
RAPIDEC® CARBA NP is a phenotypic test for rapid detection and confirmation of carbapenemase enzyme presence in Enterobacteriaceae and Pseudomonas aeruginosa isolated colonies FDA UDI
Model / Reference
RAPIDEC® CARBA NP FDA UDI
Description
RAPIDEC® CARBA NP is a phenotypic test for rapid detection and confirmation of carbapenemase enzyme presence in Enterobacteriaceae and Pseudomonas aeruginosa isolated colonies FDA UDI

Identifiers

Primary DI / UDI-DI
03573026464370 FDA UDI
510(k) Number
K162385 FDA UDI
FDA Product Code
PTJ FDA UDI
GMDN Term
Multiple bacteria carbapenemase production IVD, kit, chromogenic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

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 bacteria carbapenemase production IVD, kit, chromogenic

Rapidec® Carba Np by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria carbapenemase production IVD, kit, chromogenic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 27c355ef-5c3b-42dd-9e2a-cd5e63463e6b 35 fields · synced Jun 8, 2026