Identity
- Trade Name
- EON 100 CK REAGENT FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 77327 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540200120 FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, kit, spectrophotometry FDA UDI
Classification
- Commercial Distribution
- Not 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
Eon 100 Ck Reagent by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitalscientific
Sources (1)
- FDA UDI e0f19cf6-c2aa-4cee-98b8-5b103d511d6e 33 fields · synced Jun 8, 2026