FDA.reportPublic FDA data

QwikCheck Test Strip QC Kit

Primary DI
07290016650440
Brand
QwikCheck Test Strip QC Kit
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
QwikCheck Test Strip QC Kit
Published
2022-01-05
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016650440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016650440072900166504407290016650440

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.

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
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
07290016650082YO Home Sperm TestFor Galaxy 72017-01-22
07290016650341YO Home Sperm TestYO: Universal 2.0 packed kit - 2 testsYO-FA-01633-002020-03-31