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SPIFE ALP Separation Enhancer

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
SPIFE ALP Separation Enhancer FDA UDI
Generic Name
Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
Model / Reference
3348 FDA UDI

Identifiers

Primary DI / UDI-DI
M52533480 FDA UDI
510(k) Number
K020625 FDA UDI
FDA Product Code
CIN FDA UDI
GMDN Term
Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1050 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: Alkaline phosphatase (ALP) isoenzyme IVD, reagent

SPIFE ALP Separation Enhancer by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alkaline phosphatase (ALP) isoenzyme IVD, reagent.

Cleared under the same submission

K020625 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 3983524e-dfa7-4158-93b5-857e28d533d3 34 fields · synced Jun 9, 2026