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SPIFE Alkaline Hemoglobin Gel Kit

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
SPIFE Alkaline Hemoglobin Gel Kit FDA UDI
Generic Name
Inherited haemoglobinopathy IVD, reagent FDA UDI
Model / Reference
551977 FDA UDI

Identifiers

Primary DI / UDI-DI
M5255519770 FDA UDI
510(k) Number
K982426 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 Alkaline Hemoglobin Gel 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.

Cleared under the same submission

K982426 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI 9719e479-7eec-4e5b-887e-50ba4c1bdaf0 34 fields · synced Jun 9, 2026