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Bd Max™ Ct/Gc/Tv

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD MAX™ CT/GC/TV FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer FDA UDI
Model / Reference
442970 FDA UDI
Description
BD MAX™ CT/GC/TV Contains: 24 each, Master Mix, Extraction Tubes, Septum Caps, Strips-Containing, Wash Buffer, Elution Buffer, Neutralization Buffer FDA UDI

Identifiers

Catalog Number
442970 FDA UDI
Primary DI / UDI-DI
00382904429706 FDA UDI
510(k) Number
K151589 FDA UDI
FDA Product Code
OUY FDA UDI
MKZ FDA UDI
LSL FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3860 FDA UDI
866.3120 FDA UDI
866.3390 FDA UDI
Commercial Distribution
Not 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

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 Max™ Ct/Gc/Tv by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 92fbd0a6-e5d6-43d1-8ba8-919a5078c971 38 fields · synced May 31, 2026