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Chlamydia Antigen Substrate, 12 wells, For IFA Test System

FDA UDI

Class I (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
Chlamydia Antigen Substrate, 12 wells, For IFA Test System FDA UDI
Generic Name
Multiple Chlamydia species total antibody IVD, reagent FDA UDI
Model / Reference
CH-4112 FDA UDI

Identifiers

Catalog Number
CH-4112 FDA UDI
Primary DI / UDI-DI
B110CH41120 FDA UDI
510(k) Number
K894625 FDA UDI
FDA Product Code
LKI FDA UDI
GMDN Term
Multiple Chlamydia species total antibody IVD, reagent 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

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 Chlamydia species total antibody IVD, reagent

Chlamydia Antigen Substrate, 12 wells, For IFA Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K894625 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bion Enterprises, Ltd.

Sources (1)

  • FDA UDI e3b4a928-f6b3-4f02-abcf-9ceb913d170c 36 fields · synced May 29, 2026