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Respdirect™

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
RESPDIRECT™ FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI
Device Name
RespDirect™ Collection Kit, 50 count. FDA UDI
Model / Reference
RESPDIRECT COLLECTION KIT, US-KIT, BOX FDA UDI
Description
RespDirect™ Collection Kit, 50 count. FDA UDI

Identifiers

Catalog Number
PRD-07788 FDA UDI
Primary DI / UDI-DI
25420045516691 FDA UDI
510(k) Number
K222736 FDA UDI
FDA Product Code
QOF FDA UDI
GMDN Term
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3981 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: Oral/upper respiratory tract specimen collection kit IVD, clinical

Respdirect™ by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/upper respiratory tract specimen collection kit IVD, clinical.

Cleared under the same submission

K222736 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 3132ba3a-df1b-4a37-ad25-a89d1960b228 37 fields · synced May 31, 2026