Identity
- Trade Name
- Oral-Eze FDA UDI
- Generic Name
- Drug-testing specimen collection kit IVD FDA UDI
- Device Name
- ORAL-EZE ORAL COLL SYS FDA UDI
- Model / Reference
- 96100 FDA UDI
- Description
- ORAL-EZE ORAL COLL SYS FDA UDI
Identifiers
- Catalog Number
- 96100 FDA UDI
- Primary DI / UDI-DI
- 00859952006000 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
Yes
FDA UDI
Category: Drug-testing specimen collection kit IVD
Oral-Eze by Capitol Vial, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drug-testing specimen collection kit IVD.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Therapak — Therapak LLC · Class I
- Therapak — Therapak LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Therapak — Therapak LLC · Class I
- Therapak — Therapak LLC · Class I
- Therapak — Therapak LLC · Class I
- Oral-Eze Sample Extractor — Microgenics Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Capitol Vial, Inc.
Sources (1)
- FDA UDI dc46312c-c858-4877-8d4e-ac235a35a4a0 36 fields · synced May 30, 2026