FDA.reportPublic FDA data

QwikCheck DFI Kit

Primary DI
07290016650617
Brand
QwikCheck DFI Kit
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
QwikCheck DFI Kit: 10 Tests
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IAFWright'S Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IAFWright'S StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016650617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016650617072900166506177290016650617

GMDN Terms#

Term, Definition table
TermDefinition
Sperm energy status and motility testing reagent IVDA sterile substance or reactant intended to be added to a semen specimen during a spermiogram test, in order to assess the energy status and the potential for increasing the motility rate of sperm through clinical treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514680529
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012140792SQA-Vision Sperm Quality AnalyzerVS-MA-00892-00VS-MA-00892-002016-09-23
07290016650037SQA-V Sperm Quality AnalyzerAS-9081000AS-90810002016-09-23
07290016650822SQA-iOw Sperm Quality AnalyzerSQA-iOw Sperm Quality Analyzer2025-05-21
07290016650754YO Home Sperm TestYO 3.02025-01-16
07290016650761YO Home Sperm TestYO 3.0: Refill Pack of 3 Tests2025-01-16
07290016650778YO Home Sperm TestYO: Universal 3.0 packed kit for PROOV - 3 tests2025-01-16
07290016650785YO Home Sperm TestYO: Universal 3.0 packed kit for Bird & Be - 3 tes2025-01-16
07290016650792YO Home Sperm TestYO: Universal 3.0 packed kit for Quest Diagnostics2025-01-16
07290016650402SQA-iO Sperm Quality AnalyzerSQA-iO Sperm Quality Analyzer2023-09-06
07290012140136QwikCheck BeadsQwikCheck Beads 3 Levels2023-06-08
07290012140143QwikCheck Dilution KitQwikCheck Dilution Kit2023-06-08
07290012140150QwikCheck LiquefactionQwikCheck Liquefaction- 20 Vials2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitQwikCheck Beads Proficiency and Training Kit2023-06-08
07290012140891QwikCheck Vitality KitQwikCheck Vitality Kit- 5 Vials2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitQwikCheck Beads Precision and Linearity kit2023-06-08
07290016650587YO Home Sperm TestYO Universal 2.0 packed kit for BirdandBe - 2 testYO-FA-01912-002023-01-01
07290012140167QwikCheck Test Strips070007002016-09-29
07290016650440QwikCheck Test Strip QC KitQwikCheck Test Strip QC Kit2022-01-05
07290016650082YO Home Sperm TestFor Galaxy 72017-01-22
07290016650341YO Home Sperm TestYO: Universal 2.0 packed kit - 2 testsYO-FA-01633-002020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414619262Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414626253Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323619Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323633Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2026-02-06
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.IAF2025-02-16
00673693090391EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-10-21
00673693067744EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-06
00673693068161EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00673693090384EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00673693090407EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIAF2024-09-05
00860011780502Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00860011780519Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00860011780526Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
04048474058277Histamine ELISA DRG Instruments Gesellschaft mit beschränkter HaftungIAF2023-09-01
00840239058270Histamine ELISA DRG International IncIAF2023-08-26
14719874741591LensHooke Sperm DNA fragmentation test kit (SCD assay)BONRAYBIO CO., LTD.IAF2021-11-18
00630414473499Hematek® Stain Pak - Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503936ADVIA® Autoslide Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503967ADVIA® Autoslide Modified Wright's BufferSiemens Healthcare Diagnostics Inc.IAF2020-09-24
10885380152283CARDINAL HEALTHCardinal Health 200, LLCIAF2018-01-30