FDA.reportPublic FDA data

Indiko

Primary DI
06438153001157
Brand
Indiko
Company
Thermo Fisher Scientific Oy
Model
863
Catalog number
98630000
Device description
Clinical Chemistry Analyzer
Published
2023-07-25
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110035000INDIKOThermofisher Scientific OY2011-06-28JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438153001157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438153001157064381530011576438153001157

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540096708
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438153000129Entry, TCA19520152023-07-26
06438153000143Exit, TCA19520162023-07-26
06438153000211Conveyor 600, TCA19520212023-07-26
06438153000228Conveyor 1200, TCA19520222023-07-26
06438153000235Conveyor 1500, TCA19520232023-07-26
06438153000259Conveyor 2400, TCA19520252023-07-26
06438153000266L-Turn, TCA19520272023-07-26
06438153000297Conveyor 900, TCA19520302023-07-26
06438153000303Conveyor 2100, TCA19520312023-07-26
06438153520139Buffer, TCA19520132023-07-26
06438153000099Interface, TCA ARCHITECT i2000SR19522342023-07-25
06438153000242Conveyor 1800, TCA19520242023-07-25
06438153000327Decapper Flex, TCA19520392023-07-25
06438153000358Perpendicular Bypass, TCA Vitros 5.1 FS AT19520432023-07-25
06438153000419Internal U-Turn, TCA19520462023-07-25
06438153000433Z-Turn, right, TCA19520482023-07-25
06438153000440Z-Turn, left, TCA19520492023-07-25
06438153000471Sysmex HST Interface, TCA19520542023-07-25
06438153000488Stago STA-R Interface, TCA19520552023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FS19521312023-07-25

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Primary DI, Brand, Company table
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00810053950135NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950456NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
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00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
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00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
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