ISE Reagent Pack

FDA UDI

Class I (US FDA UDI)

by Medica Corp.

Identity

Trade Name: ISE Reagent Pack FDA UDI
Generic Name: Multiple electrolyte IVD, calibrator FDA UDI
Device Name: ISE Reagent Pack for use with EasyRA Analyzers FDA UDI
Model / Reference: 5423-0041 FDA UDI
Description: ISE Reagent Pack for use with EasyRA Analyzers FDA UDI

Identifiers

Catalog Number: 5423-0041 FDA UDI
Primary DI / UDI-DI: 00386100002282 FDA UDI
510(k) Number: K070057 FDA UDI
FDA Product Code: JJY FDA UDI
JIT FDA UDI
JJE FDA UDI
JIH FDA UDI
CGZ FDA UDI
CEM FDA UDI
JGS FDA UDI
CGA FDA UDI
GMDN Term: Multiple electrolyte IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1150 FDA UDI
862.2160 FDA UDI
862.3560 FDA UDI
862.1170 FDA UDI
862.1600 FDA UDI
862.1665 FDA UDI
862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple electrolyte IVD, calibrator

ISE Reagent Pack by Medica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple electrolyte IVD, calibrator.

Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
Alinity — Abbott · Class II
Electrolyte Standard Kit — VERICHEM LABORATORIES, INC. · Class II
Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
Alfa Wassermann — Alfa Wassermann, Inc.
PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II

Cleared under the same submission

K070057 also covers:

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: Medica Corp.

Sources (1)

FDA UDI 7e2bb0ee-681f-41ef-8520-fea897e87908 37 fields · synced May 30, 2026