Identity
- Trade Name
- Alere OratectCheck FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- Positive and Negative Oral Fluid Controls FDA UDI
- Model / Reference
- OC-001 FDA UDI
- Description
- Positive and Negative Oral Fluid Controls FDA UDI
Identifiers
- Catalog Number
- OC-001 FDA UDI
- Primary DI / UDI-DI
- 00817405020201 FDA UDI
- 510(k) Number
- K103227 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
Yes
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
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: Multiple drugs of abuse IVD, calibrator
Alere OratectCheck by Instant Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103227 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Instant Technologies, Inc.
Sources (1)
- FDA UDI 0a1e6170-ab5b-4fef-a14f-9d923009c307 37 fields · synced May 30, 2026