FDA.reportPublic FDA data

hemochroma PLUS Microcuvettes

Primary DI
10722355003020
Brand
hemochroma PLUS Microcuvettes
Company
Immunostics Company, Inc
Model
100-202
Catalog number
100-202
Device description
The hemochroma PLUS Microcuvettes are used for measurement of hemoglobin concentration in human whole blood along with the hemochroma PLUS Analyzer. The hemochroma PLUS Microcuvette is inserted into a holder of hemochroma PLUS Analyzer for quantification of hemoglobin in blood
Published
2018-12-20
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
GKRSYSTEM, HEMOGLOBIN, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722355003020PrimaryGS10
80722355003029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1072235500302010722355003020
8072235500302980722355003029

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)918-0770technical@immunostics.com

Regulatory Flags#

DUNS number
119214195
Device count
200
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722355002894hema-screen SPECIFIC GOLDHSGD-25HSGD-252025-04-16
10722355002900hema-screen SPECIFIC GOLDHSGDCAS-25HSGDCAS-252025-04-16
10722355003068hema-screen SPECIFIC GOLDHSGDENV-20HSGDENV-202025-04-16
10722355001002hema-screenHS-502016-09-23
10722355001019hema-screenHS-1002016-09-23
10722355001026hema-screenHS-10002016-09-23
10722355001033hema-screenHS-342016-09-23
10722355001040hema-screenHSPP-502016-09-23
10722355001057hema-screen STATHSTAT-502016-09-23
10722355001071hema-screen SPECIFICHSSP-252016-09-21
10722355001095hema-screen SPECIFICHSSPCAS-252016-09-21
10722355001101hema-screen SPECIFICHSSPENV-202016-09-21
10722355001125hema-screenHSDV-82016-09-23
10722355001255Detector MonoIDM-252016-09-22
10722355001453Detector PersonalIDP-32016-09-20
10722355001668Detector Strep AIST-501-OBC33IDSTREP-252016-09-21
10722355002016Detector H. pyloriIHP-102016-09-22
10722355002023Detector H. pyloriIHP-302016-09-22
10722355002146hema-screen Triple 335HSTR-335CS2016-09-23
10722355002221Detector UA 10IDU-102016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSGKR2024-07-01
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHGKR2022-12-21
04048534001540DiaSpect Hemoglobin CuvettesDiaSpect Medical GmbHGKR2022-12-20
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
27311091118077HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
04048534002165DiaSpect TmEKF-diagnostic GmbHGKR2022-10-17
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
27311091118121HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002035Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHGKR2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
04048534001946DiaSpect TmEKF-diagnostic GmbHGKR2021-03-11
24048534001964DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
17311091118094HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
07311091218278HemoCue® Hb301 AnalyzerHemocue ABGKR2020-09-04
07311091118097HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.GKR2020-04-15
00894472000237B CassetteOPTI MEDICAL SYSTEMS, INC.GKR2019-08-07
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics Company, IncGKR2018-12-20
10722355003051hemochroma PLUS Starter KitImmunostics Company, IncGKR2018-12-20
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSGKR2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSGKR2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSGKR2018-09-21
10612479234090McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234120McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234144McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
17311091117318HemoCue® Hb 201 MicrocuvettesHemocue ABGKR2018-05-25