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iHealth

FDA UDI

Class II (US FDA UDI)

by Ihealth Lab Inc.

Identity

Trade Name
iHealth FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent FDA UDI
Model / Reference
EGS-2003 FDA UDI

Identifiers

Primary DI / UDI-DI
00856362005197 FDA UDI
510(k) Number
K170231 FDA UDI
FDA Product Code
LFR FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent

iHealth by Ihealth Lab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent.

Cleared under the same submission

K170231 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ihealth Lab Inc.

Sources (1)

  • FDA UDI e6d5158c-0cd0-4a94-9e7f-a17e275534f5 33 fields · synced May 30, 2026