Identity
- Trade Name
- Ethanol Standard Kit FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, calibrator FDA UDI
- Device Name
- Calibrator / Calibration Verifier FDA UDI
- Model / Reference
- 9670 FDA UDI
- Description
- Calibrator / Calibration Verifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852553007247 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
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: Ethanol (ETOH) IVD, calibrator
Ethanol Standard Kit by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, calibrator.
- Alinity — Abbott Laboratories, Inc. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Syva® Emit® Ethyl Alcohol Negative Calibrator — Siemens Healthcare Diagnostics · Class II
- Syva® Emit® Ethyl Alcohol 100 mg/dL Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- POINTE SCIENTIFIC Alcohol Standard — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
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
- Verichem Laboratories, Inc.
Sources (1)
- FDA UDI d8431e6c-c605-4976-a8cd-25d0cc0834e5 35 fields · synced May 30, 2026