Identity
- Trade Name
- Assure® Dose Normal/High Control Solution FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.) FDA UDI
- Model / Reference
- 500006 FDA UDI
- Description
- Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015482500061 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, control
Assure® Dose Normal/High Control Solution by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Arkray Usa, Inc.
Sources (1)
- FDA UDI 1bef3c1d-d84d-458d-a80f-5ff26a9b63b1 35 fields · synced Jun 8, 2026