FDA.reportPublic FDA data

CELL-DYN

Primary DI
00380740119843
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
09H73-01
Catalog number
09H7301
Device description
CELL-DYN 22 Plus Calibrator
Published
2016-09-09
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRXCalibrator For Cell IndicesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111204000CELL-DYN 22 PLUS CALIBRATORStreck2011-12-22KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740119843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740119843003807401198433807401198430380740119843

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
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
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00380740151294AlinityAbbott GmbHKRX2023-11-16
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
15099590639426COULTER AcTBeckman Coulter, Inc.KRX2016-09-23
06944904084152SC-CAL PLUS CalibratorShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2016-09-23
20844509000314Cal-Chex A Plus STRECK, INC.KRX2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRX2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRX2016-09-16
00817274020258Drew ScientificDREW SCIENTIFIC, INC.KRX2016-09-09
00812137010254CDS-LTX CONTROLCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRX2016-09-08
00856605006004MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
00856605006103MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
14987562460325XN CALSYSMEX CORPORATIONKRX2016-08-04
14987562460349XN CAL PFSYSMEX CORPORATIONKRX2016-08-04
14987562460585X-CAL CalibratorSYSMEX CORPORATIONKRX2016-08-04
10815762020473Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020503Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020541Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020930Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762021166Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020470Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020937Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
30815762020477Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00815762020483Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00380740017071CELL-DYNABBOTT LABORATORIESKRX2016-06-06