FDA.report

ORTHO Daily QC Simulated Whole Blood Quality Control Kit

Primary DI
04065266566086
Brand
ORTHO Daily QC Simulated Whole Blood Quality Control Kit
Company
MILLIPORE (U.K.) LIMITED
Model
6708858
Catalog number
6708858
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KSFKit, Quality Control For Blood Banking Reagents

Product Code Classifications

CodeDeviceSpecialtyClass
KSFKit, Quality Control For Blood Banking ReagentsHematology2

Premarket Submissions

SubmissionSupplement
BK2106530

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2106530

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04065266566086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04065266566086040652665660864065266566086

GMDN Terms

TermDefinition
Non-blood cell primer/calibrator/control material IVD, reagentA substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify002-8oC

Sterilization Methods

Method

Regulatory Flags

DUNS number
221110203
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10888234002307Capture-R Ready Indicator Red CellsIMMUCOR, INC.KSF2022-09-03
05060242472459ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472336ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
23661562105438Neg ControlDIAGASTKSF2018-05-01
07611969952342IH-Internal QCBio-Rad Medical Diagnostics GmbHKSF2018-04-05
07611969952335IH-Basic QCBio-Rad Medical Diagnostics GmbHKSF2018-02-28
00816784020871ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2017-12-01
00816784020888ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2017-12-01
00858352006122MQCHEMO BIOSCIENCE INCKSF2017-06-28
00858352006139MQC-CATHEMO BIOSCIENCE INCKSF2017-06-26
05060242470943AlbaQ-Chek® ALBA BIOSCIENCE LIMITEDKSF2017-03-29
00816784020772ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2017-03-09
07611969952212IH-Card ControlBio-Rad Medical Diagnostics GmbHKSF2017-01-20
00858352006009Hemo-QCHEMO BIOSCIENCE INCKSF2016-10-20
00858352006016C3 Control CellsHEMO BIOSCIENCE INCKSF2016-09-29
00816784020437ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-27
05060242471162ALBAcyte IgG Sensitized Red Blood CellsALBA BIOSCIENCE LIMITEDKSF2016-09-24
00816784020024ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020031ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020048ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020055ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020062ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020123ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020215ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020222ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020451ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020468ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24
00816784020475ACCURUN®SERACARE LIFE SCIENCES, INC.KSF2016-09-24