Identity
- Trade Name
- GLYCOMARK FDA UDI
- Generic Name
- 1,5-Anhydroglucitol IVD, calibrator FDA UDI
- Device Name
- Calibration Standard 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control FDA UDI
- Model / Reference
- NK-8320 FDA UDI
- Description
- Calibration Standard 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987170775579 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- 1,5-Anhydroglucitol IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: 1,5-Anhydroglucitol IVD, calibrator
Glycomark by Nippon Kayaku Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 1,5-Anhydroglucitol IVD, calibrator.
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
- Nippon Kayaku Co., Ltd.
Sources (1)
- FDA UDI afcf056e-c89b-4bdf-9669-118b6a063287 36 fields · synced May 30, 2026