Identity
- Trade Name
- EM 15 Blood Glucose Level 2 Control Solution FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- a bottle of level 2 control solution FDA UDI
- Model / Reference
- EM44 FDA UDI
- Description
- a bottle of level 2 control solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885017000638 FDA UDI
- 510(k) Number
- K112272 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose IVD, control 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
Yes
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, control
EM 15 Blood Glucose Level 2 Control Solution by Eps Bio Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, control.
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- Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd. · Class I
- TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
Cleared under the same submission
K112272 also covers:
- 25 EasyMax 15 FTS Set EN-ES — EPS BIO TECHNOLOGY CORP.
- EM 15 Blood Glucose Level 1 Control Solution — EPS BIO TECHNOLOGY CORP.
- EM 15 Blood Glucose Level 1 and Level 2 Control Solution — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP.
- EasyMax 15 NHCS Set EN — EPS BIO TECHNOLOGY CORP.
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
- Eps Bio Technology Corp.
Sources (1)
- FDA UDI 2003c76f-6492-4306-8502-f2f09acf6b1b 36 fields · synced Jun 6, 2026