GUDIDData
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eudamed_udi Primary ID: 00627595000699

ORAcollect DNA (UDI 00627595000699)

Manufactured by DNA Genotek Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ORAcollect DNA - Primary ID 00627595000699

Device Regulatory Overview

The ORAcollect DNA (Model/Catalog Number: OCR-100) is a medical device manufactured by DNA Genotek Inc.. This product is indexed under FDA Product Code / Category Classification A1102 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-3004-2020 View Full Alert →

PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the rem...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0982-2022 View Full Alert →

ORAcollect RNA: ORE-100...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0981-2022 View Full Alert →

ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.01...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
OCR-100
Product Code / EMDN
A1102
Device Name
ORAcollect (Swab based DNA & Dx Collection Device)
Database Sync Date
2026-08-09 16:48:57

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of ORAcollect DNA?

The registered manufacturer of record for ORAcollect DNA is DNA Genotek Inc..

What is the Primary UDI-DI identifier for ORAcollect DNA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00627595000699.

What classification code is assigned to this device?

This device is registered under product classification code A1102.

Similar Classification Devices (A1102)

Other Devices by DNA Genotek Inc.

Programmatic Export

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