FDA.report

Multiple haemoglobin subtype IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple subtypes of haemoglobin in a clinical specimen.
GUDID devices
21
Last updated
2025-01-31 09:15:18

Related Product Codes

CodeDeviceSpecialtyClassDevices
GGMControl, HemoglobinHematology212
JCMControl, Hemoglobin, AbnormalHematology27
CCXSupport, Patient PositionAnesthesiology11
FMPProtector, Skin PressureGeneral Hospital11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08718734962656CueSee® CO-OXEurotrol B.V.S6B2025-01-23
00810075281446BoneFoamBONE FOAM, INC.925.PC2024-07-19
00840216113688PRIMOASP GLOBAL, LLCGGTS012022-03-18
08718734961000CueSee® CO-OXEurotrol B.V.S1A2021-12-19
08718734961062CueSee® CO-OXEurotrol B.V.S3A2021-12-19
08718734961079CueSee® CO-OXEurotrol B.V.S5A2021-12-19
08718734961086CueSee® CO-OXEurotrol B.V.LVA2021-12-19
08718734961604CueSee® CO-OXEurotrol B.V.S1B2021-12-19
08718734961611CueSee® CO-OXEurotrol B.V.S3B2021-12-19
08718734961628CueSee® CO-OXEurotrol B.V.S5B2021-12-19
08718734961635CueSee® CO-OXEurotrol B.V.LVB2021-12-19
08718734962397CueSee® CO-OXEurotrol B.V.S2B2021-12-19
08718734962403CueSee® CO-OXEurotrol B.V.S4B2021-12-19
09421902348020ExtendSURECANTERBURY SCIENTIFIC LIMITEDHB6102018-09-20
09421902348037ExtendSURECANTERBURY SCIENTIFIC LIMITEDHB110SSBAr2018-09-20
09421902348051Tosoh USCANTERBURY SCIENTIFIC LIMITED9970502018-11-02
09421902348105Tosoh EUCANTERBURY SCIENTIFIC LIMITED9970502018-11-02
05055273208832HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL)RANDOX LABORATORIES LIMITEDHA50832019-06-03
05391516744393Trinity BiotechPRIMUS CORPORATIONFASC Position Marker Kit2016-09-06
05391516744409Trinity BiotechPRIMUS CORPORATIONA2+F Control Material Kit2016-09-06
05391516748322Trinity BiotechPRIMUS CORPORATIONPremier Resolution A2+F Control Material Kit2016-09-06