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NTM Elite agar

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
NTM Elite agar FDA UDI
Generic Name
Differential/selective agar culture medium IVD FDA UDI
Device Name
selective agar plate for screening and aid to diagnosis by isolation of NTM colonies from sputum samples from cystic fibrosis patients and from respiratory specimens from non-cystic fibrosis patients FDA UDI
Model / Reference
NTM Elite agar FDA UDI
Description
selective agar plate for screening and aid to diagnosis by isolation of NTM colonies from sputum samples from cystic fibrosis patients and from respiratory specimens from non-cystic fibrosis patients FDA UDI

Identifiers

Primary DI / UDI-DI
03573026609801 FDA UDI
FDA Product Code
JSI FDA UDI
GMDN Term
Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2360 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

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: Differential/selective agar culture medium IVD

NTM Elite agar by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Differential/selective agar culture medium IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI de16b0e3-c94a-4bab-b5dc-c7f8c879f043 34 fields · synced May 30, 2026