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Accuprobe®

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
ACCUPROBE® FDA UDI
Generic Name
Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
AccuProbe® Mycobacterium intracellulare. FDA UDI
Model / Reference
KIT,ACCUPROBE,M.INTRACELLULARE FDA UDI
Description
AccuProbe® Mycobacterium intracellulare. FDA UDI

Identifiers

Catalog Number
102840 FDA UDI
Primary DI / UDI-DI
15420045506121 FDA UDI
FDA Product Code
LQF FDA UDI
GMDN Term
Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3370 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

No

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 Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT)

Accuprobe® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Mycobacterium species nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 576eccfa-ca94-4bfa-be9f-5408b4f30e4a 36 fields · synced May 30, 2026