FDA.reportPublic FDA data

Cal-Chex

Primary DI
20844509000246
Brand
Cal-Chex
Company
STRECK, INC.
Model
221101
Catalog number
221101
Device description
A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
Published
2016-09-16
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
KRZCalibrator For Hemoglobin And Hematocrit Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840261000CAL-CHEX, A HEMATOLOGY CALIBRATORStreck Laboratories, Inc.1984-02-21KRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20844509000246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084450900024620844509000246

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

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
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16
10844509000096CD-Chex Plus2133302133302016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRZ2026-02-06
00380740151294AlinityAbbott GmbHKRZ2023-11-16
00630414224343ADVIA® 120/2120/2120i SETpointSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
04015630921096Cfas HbA1cRoche Diagnostics GmbHKRZ2016-09-20
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRZ2016-09-16
00847817000324VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817011979VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817013966VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014154VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014406VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014871VARIANT II TURBO LinkBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00380740003609ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003616ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003623ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00812137010223Boule CalCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-06
00812137010360CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00812137010421CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00380740017071CELL-DYNABBOTT LABORATORIESKRZ2016-06-06
00380740020347CELL-DYNABBOTT LABORATORIESKRZ2016-06-06