FDA.reportPublic FDA data

VerséaTM Ophthalmics 4.3” Lateral Flow Reader

Primary DI
00860009215108
Brand
VerséaTM Ophthalmics 4.3” Lateral Flow Reader
Company
Axim Biotechnologies, Inc.
Model
100033000
Catalog number
900033000VE
Published
2022-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009215115PackageGS11In Commercial Distribution
00860009215108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009215115008600092151158600092151150860009215115
00860009215108008600092151088600092151080860009215108

GMDN Terms#

Term, Definition table
TermDefinition
Photometric/spectroscopic immunoassay analyser IVDAn electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.

Regulatory Flags#

DUNS number
079498248
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
00860009215122Axim Biotechnologies T-POC Lactoferrin Immunoassay KitCP0002CP00022024-03-27
00860009215139T-POC TOTAL IgE IMMUNOASSAY KITCP0001CP00012024-03-27
00860009215115VerséaTM Ophthalmics 4.3” Lateral Flow Reader100033000900033000VE2022-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisCODONICS INC.JJQ2026-04-20
05430003908815SEEKER®Lacar MDX TechnologiesJJQ2026-01-15
00850049545501Diagnostic Automation, Inc.Diagnostic Automation, Inc.JJQ2025-12-24
00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300229BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300236BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300243BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05