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Api® 20 A

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
API® 20 A FDA UDI
Generic Name
Multiple anaerobic bacteria species culture isolate identification IVD, kit FDA UDI
Device Name
The API 20 A system enables 21 tests to be carried out for ID of anaerobes. Other tests such as colonial and microscopic morphology, Gram stain, etc. to confirm or complete ID FDA UDI
Model / Reference
20300 FDA UDI
Description
The API 20 A system enables 21 tests to be carried out for ID of anaerobes. Other tests such as colonial and microscopic morphology, Gram stain, etc. to confirm or complete ID FDA UDI

Identifiers

Primary DI / UDI-DI
03573026048150 FDA UDI
FDA Product Code
JSP FDA UDI
GMDN Term
Multiple anaerobic bacteria species culture isolate identification IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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

Api® 20 A by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 1a5a81d5-3f71-4641-a79f-96a8fbce660b 34 fields · synced May 29, 2026