FDA.reportPublic FDA data

QwikCheck Beads Precision and Linearity kit

Primary DI
07290016650020
Brand
QwikCheck Beads Precision and Linearity kit
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
QwikCheck Beads Precision and Linearity kit
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
JJWUrinalysis Controls (Assayed And Unassayed)
NRFMaterial, Quality Control, Semen Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1
NRFMaterial, Quality Control, Semen AnalysisHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041600000QWIKCHECK-BEADSMedical Electronics Systems , Ltd.2004-07-27NRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016650020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016650020072900166500207290016650020

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
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
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
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
04719874742652LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-16
04719874742614LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742621LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742638LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742669LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
00860010518106Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518113Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518120Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518137Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
08600105181066Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181134Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181202Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181370Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08