FDA.reportPublic FDA data

QwikCheck Liquefaction

Primary DI
07290012140150
Brand
QwikCheck Liquefaction
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
QwikCheck Liquefaction- 20 Vials
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
IBGTrypsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBGTrypsinPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012140150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012140150072900121401507290012140150

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
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
07290016650617QwikCheck DFI KitQwikCheck DFI Kit: 10 Tests2023-06-08
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
04719874741242LensHooke Liquefaction EnzymeBONRAYBIO CO., LTD.IBG2025-02-16
04719874741259LensHooke Liquefaction EnzymeBONRAYBIO CO., LTD.IBG2025-02-13
04015630971138PROTEASE 1Ventana Medical Systems, Inc.IBG2021-01-29
04015630971145PROTEASE 2Ventana Medical Systems, Inc.IBG2021-01-29
04015630971152PROTEASE 3Ventana Medical Systems, Inc.IBG2021-01-29
04015630971862ISH PROTEASE 1Ventana Medical Systems, Inc.IBG2021-01-29
04015630971879ISH PROTEASE 2Ventana Medical Systems, Inc.IBG2021-01-29
04015630971886ISH PROTEASE 3Ventana Medical Systems, Inc.IBG2021-01-29