Identity
- Trade Name
- V8 Velocity CE Analyzer (110V) Inpeco Ready FDA UDI
- Generic Name
- Electrophoresis analyser IVD FDA UDI
- Model / Reference
- 1800001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52518000010 FDA UDI
- 510(k) Number
- K111369 FDA UDI
- FDA Product Code
- CFF FDA UDI
- GMDN Term
- Electrophoresis analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrophoresis analyser IVD
V8 Velocity CE Analyzer (110V) Inpeco Ready by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrophoresis analyser IVD.
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- V8 Velocity CE Analyzer (110V) Not Inpeco Ready — Helena Laboratories, Corp. · Class II
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- SPIFE Touch, CSA 2015 (120V) — Helena Laboratories, Corp. · Class I
Cleared under the same submission
K111369 also covers:
- V8 E-Class Velocity CE Analyzer (220V) — Helena Laboratories, Corp.
- V8 Gel IFE Diluent Barcode Labels — Helena Laboratories, Corp.
- V8 Immunodisplacement Kit — Helena Laboratories, Corp.
- V8 Nexus CE Analyzer (115V/230V) — Helena Laboratories, Corp.
- V8 Velocity CE Analyzer (110V) Not Inpeco Ready — Helena Laboratories, Corp.
- V8 WASTE DRAWER PACK — Helena Laboratories, 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 7d3abd52-20a7-4811-82db-e6b527457e90 34 fields · synced Jun 9, 2026