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BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack

FDA UDI

Class I (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack FDA UDI
Generic Name
Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack FDA UDI
Model / Reference
442959 FDA UDI
Description
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack FDA UDI

Identifiers

Catalog Number
442959 FDA UDI
Primary DI / UDI-DI
00382904429591 FDA UDI
510(k) Number
K140446 FDA UDI
FDA Product Code
MKZ FDA UDI
GMDN Term
Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3120 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

Yes

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: Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)

BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Chlamydia trachomatis 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
Becton Dickinson And Company

Sources (1)

  • FDA UDI dc90b96d-b3b4-4a24-860a-462674c67a9e 37 fields · synced Jun 8, 2026