Identity
- Trade Name
- Square Cuvettes for HemeSpec Plus (500/pkg) FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Model / Reference
- 1104000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52511040000 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Laboratory analyser cuvette IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory analyser cuvette IVD, single-use
Square Cuvettes for HemeSpec Plus (500/pkg) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory analyser cuvette IVD, single-use.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 0a88e028-3308-471b-a14d-f08ec10da7a2 33 fields · synced Jun 9, 2026