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Finder

FDA UDI

Class II (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
FINDER FDA UDI
Generic Name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence FDA UDI
Device Name
FINDER G6PD TEST (Unit of Use) FDA UDI
Model / Reference
110-000014 FDA UDI
Description
FINDER G6PD TEST (Unit of Use) FDA UDI

Identifiers

Primary DI / UDI-DI
00819704020364 FDA UDI
510(k) Number
K201049 FDA UDI
FDA Product Code
JBF FDA UDI
GMDN Term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7360 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence

Finder by Baebies 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, kit, enzyme fluorescence.

Cleared under the same submission

K201049 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI a4316b98-2fc9-477c-9595-4f9d1ca7a781 35 fields · synced Jun 8, 2026