iFlash 9000 CLIA Analyzer

FDA UDI

Class I (US FDA UDI)

by Shenzhen YHLO Biotech Co., Ltd.

Identity

Trade Name: iFlash 9000 CLIA Analyzer FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Device Name: Type A, autoload FDA UDI
Model / Reference: iFlash 9000-A FDA UDI
Description: Type A, autoload FDA UDI

Identifiers

Catalog Number: FG0076 FDA UDI
Primary DI / UDI-DI: 06925912718154 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Chemiluminescent immunoassay analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD

iFlash 9000 CLIA Analyzer by Shenzhen YHLO Biotech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Alinity — Abbott Laboratories, Inc. · N

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

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Manufacturer

Manufacturer: Shenzhen YHLO Biotech Co., Ltd.

Sources (1)

FDA UDI feb3de0c-3f79-40c1-b19a-f4a01a0ff3cc 34 fields · synced May 31, 2026