FDA.reportPublic FDA data

e-CHECK

Primary DI
14987562460288
Brand
e-CHECK
Company
SYSMEX CORPORATION
Model
199-4004-1
Device description
E-Check 4X4.5MLX3 Low/Normal/High
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLQMIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES
JPKMIXTURE, HEMATOLOGY QUALITY CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLQMixture, Control, White-Cell And Red-Cell IndicesHematology2
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994388000XE CHECKStreck Laboratories, Inc.2000-01-14GLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14987562460288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1498756246028814987562460288

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015924209ST 201 Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924216ST 201-B Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290089Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290096Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290102Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00860001900538IntelliSep Quality Control KitCytovale IncJPK2025-07-03
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04