FDA.reportPublic FDA data

Viva-ProE

Primary DI
03701700860358
Brand
Viva-ProE
Company
VitalScientific B.V.
Model
Viva-ProE
Catalog number
6003-760
Published
2025-04-30
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
K102647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102647000ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BV2011-03-24JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701700860358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701700860358037017008603583701700860358

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
494028946
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540600357Viva-ProE®6003-7602017-04-21
03661540600395Selectra ProM 6003-4352016-11-18
03661540600418SelectraProS6003-6002016-11-18
03701700860396SelectraProM6003-4352025-05-06
03701700860419SelectraProS6003-6002025-05-06
03661540600180V-Twin®6002-8002016-11-21
03661540600050Viva-E®6002-3802016-11-21
03661540600210Viva-Jr®6002-9402016-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024548NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
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
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22