Identity
- Trade Name
- YSI Incorporated FDA UDI
- Generic Name
- Glucose IVD, calibrator FDA UDI
- Device Name
- 2367 GLUCOSE STD,10.0 MMOL/L FDA UDI
- Model / Reference
- 2367 FDA UDI
- Description
- 2367 GLUCOSE STD,10.0 MMOL/L FDA UDI
Identifiers
- Catalog Number
- 098089 FDA UDI
- Primary DI / UDI-DI
- 00851683007035 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Glucose IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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: Glucose IVD, calibrator
YSI Incorporated by Ysi Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, calibrator.
- Nova Primary — NOVA BIOMEDICAL CORPORATION · Class II
- Nova Primary — NOVA BIOMEDICAL CORPORATION · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. Glucose Standard — POINTE SCIENTIFIC, INC. · Class II
- YSI Incorporated — YSI INCORPORATED · Class II
- YSI Incorporated — YSI INCORPORATED · Class II
- YSI Incorporated — YSI INCORPORATED · Class II
- YSI Incorporated — YSI INCORPORATED · 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
- Ysi Incorporated
Sources (1)
- FDA UDI 54bd27ad-422d-485b-92d0-c537a2fd8a4c 34 fields · synced May 31, 2026