FDA.reportPublic FDA data

CELL-DYN

Primary DI
00380740017071
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
08H57-01
Catalog number
08H5701
Device description
CELL-DYN HemCal Plus Calibrator
Published
2016-06-06
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
KRXCALIBRATOR FOR CELL INDICES
KRYCALIBRATOR FOR PLATELET COUNTING
KRZCALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT
KSACALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRXCalibrator For Cell IndicesHematology2
KRYCalibrator For Platelet CountingHematology2
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2
KSACalibrator For Red-Cell And White-Cell CountingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020469000CAL-CHEX CD PLUSStreck Laboratories, Inc.2002-04-04KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740017071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740017071003807400170713807400170710380740017071

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.

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(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KSA2026-02-06
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRZ2026-02-06
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRY2026-02-06
00815762023446Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
00815762023453Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
06936415992927SC-CAL PLUSShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2025-01-17
03610230009611ABX MinocalHORIBA ABX SASKSA2024-09-27
00380740151294AlinityAbbott GmbHKRZ2023-11-16
00380740151294AlinityAbbott GmbHKRX2023-11-16
00380740151294AlinityAbbott GmbHKRY2023-11-16
00380740151294AlinityAbbott GmbHKSA2023-11-16
14987562460332XN CALSYSMEX CORPORATIONKRX2017-10-06
14987562460356XN CAL PFSYSMEX CORPORATIONKRX2017-10-06
14987562460592X-CAL CalibratorSYSMEX CORPORATIONKRX2017-10-06
D757U2260K1One Step Plus KITBISCO INC.KRX2017-06-12
00630414224343ADVIA® 120/2120/2120i SETpointSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
15099590221881COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590233679COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590233761COULTER S-CAL Beckman Coulter, Inc.KRY2016-09-23
15099590639426COULTER AcTBeckman Coulter, Inc.KRX2016-09-23
06944904084152SC-CAL PLUS CalibratorShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2016-09-23
04015630921096Cfas HbA1cRoche Diagnostics GmbHKRZ2016-09-20
20844509000246Cal-ChexSTRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRY2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRX2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KSA2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16