Identity
- Trade Name
- Yumizen C1200 Amylase FDA UDI
- Generic Name
- Amylase isoenzyme IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 1300023831 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006849 FDA UDI
- 510(k) Number
- K070249 FDA UDI
- FDA Product Code
- JFJ FDA UDI
- GMDN Term
- Amylase isoenzyme IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Amylase isoenzyme IVD, kit, spectrophotometry
Yumizen C1200 Amylase by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amylase isoenzyme IVD, kit, spectrophotometry.
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227 — Carolina Liquid Chemistries Corp. · Class II
- ADVIA® Chemistry PAMY Pancreatic Amylase Reagents — Siemens Healthcare Diagnostics · Class II
- AMYP Amylase EPS Pancreatic — Roche Diagnostics Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227 — Carolina Liquid Chemistries Corp. · Class II
- alpha-Amylase EPS Pancreatic — Roche Diagnostics Corp. · Class II
- a-Amylase EPS Pancreatic — Roche Diagnostics Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K070249 also covers:
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
- Horiba Abx
Sources (1)
- FDA UDI 99b719ab-5f71-442b-aa1c-814e5dcfa345 33 fields · synced Jun 8, 2026