← Back to catalogue

Rapid Id 32 A

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 541052

by Biomerieux , Inc.

Identity

Trade Name
RAPID ID 32 A EUDAMEDFDA UDI
Generic Name
Multiple anaerobic bacteria species culture isolate identification IVD, kit FDA UDI
Device Name
RAPID ID 32 A EUDAMED
rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours FDA UDI
Model / Reference
541052 EUDAMED
RAPID ID 32 A FDA UDI
Description
rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours FDA UDI

Identifiers

Primary DI / UDI-DI
03573026588564 EUDAMEDFDA UDI
Basic UDI-DI
357302BUDI000095TF EUDAMED
FDA Product Code
JSP FDA UDI
EMDN Code
W0104080299 MANUAL IDENTIFICATION - OTHER EUDAMED
GMDN Term
Multiple anaerobic bacteria species culture isolate identification IVD, kit FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Yes

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 anaerobic bacteria species culture isolate identification IVD, kit

Rapid Id 32 A by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple anaerobic bacteria species culture isolate identification IVD, kit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (2)

  • FDA UDI 9e8c288b-b368-417a-a00b-8bc1c42cf16a 34 fields · synced Jun 19, 2026
  • EUDAMED 26c77bae-7b5a-49cc-9840-92bb133bd318 61 fields · synced Jun 19, 2026