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binx io

FDA UDI

Class II (US FDA UDI)

by Binx Health, Inc.

Identity

Trade Name
binx io FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
binx io CT/NG cartridge FDA UDI
Model / Reference
V1 (CT/NG) FDA UDI
Description
binx io CT/NG cartridge FDA UDI

Identifiers

Catalog Number
1.002.101 FDA UDI
Primary DI / UDI-DI
05060441760050 FDA UDI
510(k) Number
K200533 FDA UDI
FDA Product Code
QEP 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
866.3393 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

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-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

binx io by Binx Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K200533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Binx Health, Inc.

Sources (1)

  • FDA UDI 225c0689-36a8-419b-8dfe-48009b36c878 35 fields · synced May 30, 2026