Identity
- Trade Name
- SPIFE LD Gel Kit FDA UDI
- Generic Name
- Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent FDA UDI
- Model / Reference
- 552610 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M5255526100 FDA UDI
- 510(k) Number
- K020467 FDA UDI
- FDA Product Code
- CFE FDA UDI
- GMDN Term
- Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1445 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent
SPIFE LD Gel Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent.
- CAROLINA LIQUID CHEMISTRIES CORP.™ LD-L REAGENT CC205 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® LDH RGT. KIT BL-205 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® LDH RGT. KIT AU-205 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® LDH REAGENT PRODUCT NO. DT205 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 LDH RGT KIT Product No. ST205 — Carolina Liquid Chemistries Corp. · Class II
- Blade Applicator Kit, 20 Sample — Helena Laboratories, Corp. · Class II
- SPIFE LD Gel Kit — Helena Laboratories, Corp. · Class II
- SPIFE LD Reagent Kit — Helena Laboratories, Corp. · Class II
Cleared under the same submission
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 6a8d9a08-0495-46ea-92cb-b2a0fa46e3fc 34 fields · synced Jun 9, 2026