FDA.reportPublic FDA data

Sperm-Chex

Primary DI
00844509001867
Brand
Sperm-Chex
Company
STRECK, INC.
Model
230202
Catalog number
230202
Device description
A sperm count control containing stabilized sperm. Contains 1 vial each of level 1 & 2.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRFMaterial, Quality Control, Semen Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRFMaterial, Quality Control, Semen AnalysisHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041240000SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYEDFertility Solutions, Inc.2004-06-02NRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844509001867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844509001867008445090018678445090018670844509001867

GMDN Terms#

Term, Definition table
TermDefinition
Sperm concentration indicator IVD, controlA material that is used to verify the performance of an assay intended to be used to indicate the concentration of sperm in a semen specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume300Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.NRF2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
00858604006016accu-beads®HAMILTON THORNE, INC.NRF2022-03-30
04719874741037LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741044LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741051LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741082LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741099LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874740832LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740849LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740856LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740863LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740870LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740887LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740894LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740900LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16