Identity
- Trade Name
- Cuvette Conditioner EX FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Model / Reference
- 781611431 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987762129810 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Multiple clinical chemistry enzyme IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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: Multiple clinical chemistry enzyme IVD, control
Cuvette Conditioner EX by Jeol — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry enzyme IVD, control.
- FastPack® Control Kit — QUALIGEN INC. · Class I
- Enzymer Verifier Kit — VERICHEM LABORATORIES, INC. · Class I
- POINTE SCIENTIFIC Ammonia/Alcohol Controls — POINTE SCIENTIFIC, INC. · Class I
- ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) — Randox Laboratories, Ltd. · Class I
- Dimension® Enzyme Verifier — Siemens Healthcare Diagnostics · Class I
- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class I
- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class I
- DBS Controls M2 — Wallac, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jeol
Sources (1)
- FDA UDI b820e1b1-5eeb-41d8-9416-489b8216fdd1 32 fields · synced May 29, 2026