Identity
- Trade Name
- POINTE SCIENTIFIC ALCOHOL FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- A7504-150 FDA UDI
- Description
- For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- A7504-150 FDA UDI
- Primary DI / UDI-DI
- 00811727010063 FDA UDI
- 510(k) Number
- K972725 FDA UDI
- FDA Product Code
- DIC FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3040 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, kit, enzyme spectrophotometry
Pointe Scientific Alcohol by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, kit, enzyme spectrophotometry.
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- Ethanol Gen2 — Roche Diagnostics Corp. · Class II
- Ethanol Gen.2 — Roche Diagnostics Corp. · Class II
- Pointe Ethyl Alcohol Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- POINTE SCIENTIFIC ALCOHOL — POINTE SCIENTIFIC, INC. · Class II
- Pointe Ethyl Alcohol Reagent Set — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K972725 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 08067c3b-98a3-48e7-9b3b-5f518a44480c 37 fields · synced May 29, 2026