Identity
- Trade Name
- POINTE SCIENTIFIC Alcohol Standard FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, calibrator FDA UDI
- Device Name
- The Alcohol standard is intended as a means of calibrating various ethanol assay methods. FDA UDI
- Model / Reference
- A7504-STD FDA UDI
- Description
- The Alcohol standard is intended as a means of calibrating various ethanol assay methods. FDA UDI
Identifiers
- Catalog Number
- A7504-STD FDA UDI
- Primary DI / UDI-DI
- 00811727010087 FDA UDI
- 510(k) Number
- K882117 FDA UDI
- FDA Product Code
- DNN FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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
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: Ethanol (ETOH) IVD, calibrator
POINTE SCIENTIFIC Alcohol Standard by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethanol (ETOH) IVD, calibrator.
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Cleared under the same submission
K882117 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 652803c7-2265-476d-ae5d-21f41e007788 37 fields · synced May 30, 2026