FDA.reportPublic FDA data

hemochroma PLUS Starter Kit

Primary DI
10722355003051
Brand
hemochroma PLUS Starter Kit
Company
Immunostics Company, Inc
Model
100-PROMO
Catalog number
100-PROMO
Device description
1 hemochroma PLUS Analyzer+100 Microcuvettes+1 optical system check
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
10722355003051PrimaryGS10
80722355003050Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1072235500305110722355003051
8072235500305080722355003050

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total haemoglobin (totHb) in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity075 Percent (%) Relative Humidity
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
100
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
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics 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