Identity
- Trade Name
- SPIFE Acid Hemoglobin Kit FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, reagent FDA UDI
- Model / Reference
- 551951 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M5255519510 FDA UDI
- 510(k) Number
- K992199 FDA UDI
- FDA Product Code
- JBD FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7440 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: Inherited haemoglobinopathy IVD, reagent
SPIFE Acid Hemoglobin Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inherited haemoglobinopathy IVD, reagent.
- Hemoglobin Variants System — Bio-Rad Laboratories · Class I
- VARIANT nbs — Bio-Rad Laboratories · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- VARIANT nbs — Bio-Rad Laboratories · Class II
- Trinity Biotech — Primus Corp. · Class II
- VARIANT nbs — Bio-Rad Laboratories · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- Hemoglobin Variants System — Bio-Rad Laboratories · Class I
Cleared under the same submission
K992199 also covers:
- QuickGel Acid Hemoglobin 10/20 Gel Kit — Helena Laboratories, Corp.
- QuickGel Applicator Blade and Shallow Well Cups — Helena Laboratories, Corp.
- SPIFE 4000 Acid Hemoglobin Kit — Helena Laboratories, Corp.
- SPIFE Acid Hemoglobin Kit — Helena Laboratories, Corp.
- SPIFE Nexus Acid Hemoglobin Kit — 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 0bfaa95e-c89c-4618-89ef-84ef13200bda 34 fields · synced Jun 9, 2026