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BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit FDA UDI
Generic Name
Urogenital specimen collection kit IVD, clinical FDA UDI
Device Name
BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit FDA UDI
Model / Reference
440476 FDA UDI
Description
BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit FDA UDI

Identifiers

Catalog Number
440476 FDA UDI
Primary DI / UDI-DI
00382904404765 FDA UDI
510(k) Number
K984631 FDA UDI
FDA Product Code
LSL FDA UDI
GMDN Term
Urogenital specimen collection kit IVD, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3390 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 85aabfce-a1c7-4ec6-9562-569fa06e5250 38 fields · synced Jun 1, 2026