FDA.reportPublic FDA data

UltraCrit QC Cuvettes

Primary DI
00831829000045
Brand
UltraCrit QC Cuvettes
Company
SEPARATION TECHNOLOGY, INC.
Model
270-112
Catalog number
270-112
Device description
UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultasound technology to accurately measure hematocrit (Hct) in whole blood.
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKFInstrument, Hematocrit, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKFInstrument, Hematocrit, AutomatedHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00831829000045PrimaryGS10
00831829000052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831829000045008318290000458318290000450831829000045
00831829000052008318290000528318290000520831829000052

GMDN Terms#

Term, Definition table
TermDefinition
Haematocrit analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to determine the red cell haematocrit or packed red cell volume of a whole blood specimen, using technology which may incorporate centrifugation, photometry or electrometry. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
195501127
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008318290004413D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)230-100D230-100D2023-11-06
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)230-100D230-100D2023-11-06
00831829000427UltraCrit Loaner100-201100-2012023-03-01
00831829000014UltraCrit100-200100-2002017-08-25
00831829000069UltraChek Reference Controls Low 300-116300-1162017-08-25
00831829000083UltraChek Reference Controls Normal300-117300-1172017-08-25
00831829000106UltraChek Reference Controls High300-118300-1182017-08-25
00831829000380UltraCrit (Refurbished)R100-200R100-2002017-09-28
00831829000410HemataSTAT II Centrifuge 100-133100-1332022-03-31
00831829000120HemataSTAT II Centrifuge 100-100100-1002017-08-25
00831829000243Tube Sealant, Hemataseal260-100260-1002017-08-25
00831829000397HemataSTAT II Centrifuge (Refurbished)R100-100R100-1002018-04-17
00831829000021UltraCrit Cuvettes 270-111270-1112017-08-25
00831829000267ClearCRIT® Plastic Capillary Tubes270-106270-1062017-08-25
00831829000281ClearCRIT® Plastic Capillary Tubes270-107270-1072017-08-25
00831829000304ClearCrit Mylar®Coated Glass Capillary Tubes 270-108270-1082017-08-25
00831829000328ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 270-109270-1092017-08-25
00831829000403ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 270-109VL270-109VL2017-12-14
00831829000366UltraCrit Cleaning Tools 320-113320-1132017-08-25
00831829000137HemataChek, Low, Normal, High Control300-102300-1022017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00831829000427UltraCrit LoanerSEPARATION TECHNOLOGY, INC.GKF2023-03-01
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONGKF2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONGKF2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONGKF2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONGKF2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONGKF2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONGKF2018-12-04
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSGKF2018-09-21
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSGKF2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSGKF2018-09-21
08426950807537GEM Premier 5000 PAK BG/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYGKF2018-01-24
00831829000380UltraCrit (Refurbished)SEPARATION TECHNOLOGY, INC.GKF2017-09-28
00831829000014UltraCritSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000021UltraCrit Cuvettes SEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000069UltraChek Reference Controls Low SEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000083UltraChek Reference Controls NormalSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00831829000106UltraChek Reference Controls HighSEPARATION TECHNOLOGY, INC.GKF2017-08-25
00385480528566STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480528573STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480534185STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480534208STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536561STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536578STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536660STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00385480536677STAT PROFILENOVA BIOMEDICAL CORPORATIONGKF2017-07-06
00630414566788RAPIDPOINT® 340/350 Valve ModuleSiemens Healthcare Diagnostics Inc.GKF2017-03-24
00630414016627RAPIDSystems™ AutomaticQC CartridgeSiemens Healthcare Diagnostics Inc.GKF2017-01-23
00630414443485RAPIDPoint® 400/405/500 Wash/Waste CartridgeSiemens Healthcare Diagnostics Inc.GKF2016-09-24
00630414443492RAPIDPoint® 400 Measurement CartridgeSiemens Healthcare Diagnostics Inc.GKF2016-09-24
00630414444581RAPIDPoint® 400/405/500 Wash/Waste CartridgeSiemens Healthcare Diagnostics Inc.GKF2016-09-24