Identity
- Trade Name
- Oral-Eze Sample Extractor FDA UDI
- Generic Name
- Drug-testing specimen collection kit IVD FDA UDI
- Model / Reference
- 96105-500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883012646 FDA UDI
- FDA Product Code
- PJD FDA UDI
- GMDN Term
- Drug-testing specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
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: Drug-testing specimen collection kit IVD
Oral-Eze Sample Extractor by Microgenics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (1)
- FDA UDI c46c9ca4-b2a9-4701-89b2-7b6e9829cdf5 32 fields · synced Jun 9, 2026