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Inocu Swabs

FDA UDI

Class I (US FDA UDI)

by Microbiologics, Inc.

Identity

Trade Name
Inocu Swabs FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Device Name
CT/GC Swab Validation Set (Chlamydia/GC) FDA UDI
Model / Reference
CTGC-VP FDA UDI
Description
CT/GC Swab Validation Set (Chlamydia/GC) FDA UDI

Identifiers

Catalog Number
CTGC-VP FDA UDI
Primary DI / UDI-DI
10634853001258 FDA UDI
FDA Product Code
JTR FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2480 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

No

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

Yes

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, control

Inocu Swabs by Microbiologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microbiologics, Inc.

Sources (1)

  • FDA UDI edd4ee05-36ae-4d17-afda-15f4ac086a55 36 fields · synced May 31, 2026