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Exact Diagnostics

FDA UDI

Class I (US FDA UDI)

by Exact Diagnostics

Identity

Trade Name
Exact Diagnostics FDA UDI
Generic Name
Human papillomavirus (HPV) nucleic acid IVD, control FDA UDI
Device Name
HPV Genotype 18 Control FDA UDI
Model / Reference
HPV18C FDA UDI
Description
HPV Genotype 18 Control FDA UDI

Identifiers

Catalog Number
HPV18C FDA UDI
Primary DI / UDI-DI
00812242030246 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Human papillomavirus (HPV) nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

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: Human papillomavirus (HPV) nucleic acid IVD, control

Exact Diagnostics by Exact Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human papillomavirus (HPV) nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exact Diagnostics

Sources (1)

  • FDA UDI 5ed63ed0-0835-44f7-9ac7-647f56d3aa2e 36 fields · synced Jun 9, 2026