FDA.reportPublic FDA data

Chemiluminescence Immunoassay Analyzer

Primary DI
06925912710547
Brand
Chemiluminescence Immunoassay Analyzer
Company
Shenzhen YHLO Biotech Co., Ltd.
Model
iFlash 3000-C
Catalog number
C6106
Device description
Type D
Published
2022-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925912710547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06925912710547069259127105476925912710547

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420735989
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925912718512iFlash-T4C860262022-10-26
06925912718703iFlash-HCGC860122024-01-30
06925912718833iFlash-Anti-Beta2-Glycoprotein IC89027Z2023-12-31
06925912710424Chemiluminescence Immunoassay AnalyzeriFlash 3000-CC61112022-10-26
06925912719205iFlash-Mycoplasma pn. IgMC88004M2022-10-26
06925912715290iFlash-Cleaning SolutionC899232022-10-26
06925912716044Wash BufferC800012022-10-26
06925912716075Trigger Solution (1×)C899982022-10-26
06925912716099Trigger Solution (1×)C899482022-10-26
06925912716105Pre-Trigger Solution (1×)C899992022-10-26
06925912716112Pre-Trigger Solution (1×)C899592022-10-26
06925912716129Pre-Trigger Solution (1×)C899492022-10-26
06925912716587Sample DiluentC899112022-10-26
06925912716600Sample DiluentC899122022-10-26
06925912716624Sample DiluentC899142022-10-26
06925912716631Sample DiluentC899152022-10-26
06925912716648Sample DiluentC899172022-10-26
06925912716679Sample DiluentC899182022-10-26
06925912716693Sample DiluentC899192022-10-26
06925912716792Sample DiluentC89919-12022-10-26

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00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
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