FDA.reportPublic FDA data

SC-CAL PLUS Calibrator

Primary DI
06944904084152
Brand
SC-CAL PLUS Calibrator
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
SC-CAL PLUS
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K955925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955925000CBC-CAL PLUS HEMATOLOGY CALIBRATORR&D Systems, Inc.1996-02-29KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904084152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904084152069449040841526944904084152

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944904003825CABLE,IBP ADAPTER, 12PIN/6PIN0010-20-427952016-09-23
06944904003856CABLE,XDUCER,IBP,EDWARD,12PIN0010-21-121792016-09-23
06944904003870CABLE,XDUCER,IBP,MEMSCAP,6PIN0010-21-430812016-09-23
06944904003887CABLE,XDUCER,IBP,MEMSCAP,12PIN0010-21-430822016-09-23
06944904003894CABLE,XDUCER,IBP,EDWARD,6PIN0010-21-430942016-09-23
06944904030838ECG adapter cable (12-pin to 6-pin)0010-30-430542016-09-23
06944904030272A5 Anesthesia SystemA52015-10-20
06944904039695A7 Anesthesia SystemA72015-10-20
06903053124348Diagnostic Ultrasound SystemMU9 Pro2026-06-03
06903053124355Diagnostic Ultrasound SystemMU9A2026-06-03
06903053124379Diagnostic Ultrasound SystemMU7 Pro2026-06-03
06903053124430Diagnostic Ultrasound SystemMU9 Super2026-06-03
06903053124461Diagnostic Ultrasound SystemMU72026-06-03
06903053124492Diagnostic Ultrasound SystemMU7 Super2026-06-03
06903053124546Diagnostic Ultrasound SystemMU9S2026-06-03
06903053124560Diagnostic Ultrasound SystemMU9P2026-06-03
06903053124591Diagnostic Ultrasound SystemMU92026-06-03
06903053124607Diagnostic Ultrasound SystemMU7S2026-06-03
06903053124614Diagnostic Ultrasound SystemMU7A2026-06-03
06903053124683Diagnostic Ultrasound SystemMU9T2026-06-03

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
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
00380740119843CELL-DYNABBOTT LABORATORIESKRX2016-09-09
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