JIT

Product Code: JIT


Products Classified as JIT

444Calibrator, SecondaryCalibrator.

Total Product Life Cycle (TPLC) Devices

444Calibrator, SecondaryCalibrator.

FDA Consensus Standards

Calibrator, Secondary [11555]21 CFR §862.1150 🔎
Calibrator, Secondary [11559]21 CFR §862.1150 🔎

Pre-market Notifications for JIT

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics
K170938CalSet IGF-1Roche Diagnostics
K170160Abbott ARCHITECT Free T3Abbott Laboratories
K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics, Inc.
K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics, Inc.
K163544Lumipulse G ProlactinFUJIREBIO DIAGNOSTICS, INC.
K163521Lumipulse G LH CalibratorsFUJIREBIO DIAGNOSTICS, INC
K163078DC-UIBC-CALSEKISUI DIAGNOSTICS P.E.I. INC.
K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics, Inc.
K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSIEMENS HEALTHCARE DIAGNOSTICS
K160113ST AIA-PACK HsE2 Calibrator SetTOSOH BIOSCIENCE, INC.
K153417ST AIA-PACK PROG III Calibrator SetTOSOH BIOSCIENCE, INC.
K152526Elecsys Progesterone III CalSetROCHE DIAGNOSTICS
K151566Abbott ARCHITECT Total T4 CalibratorsABBOTT LABORATORIES
K143342Elecsys T-Uptake CalsetRoche Diagnostics

Global Unique Device Identification Database

00385480400947CALIBRATOR, SECONDARY
00385480387323CALIBRATOR, SECONDARY
00385480380430CALIBRATOR, SECONDARY
00385480369213CALIBRATOR, SECONDARY
00380740154479Calibrator, secondary
00380740154462Calibrator, secondary
00380740153939Calibrator, secondary
00380740153588Calibrator, secondary
00380740153540Calibrator, secondary
00380740151379Calibrator, secondary
00380740151256Calibrator, secondary
00380740150792Calibrator, secondary
00380740150594Calibrator, secondary
00380740150570Calibrator, secondary
00380740145347Calibrator, secondary

Maude Adverse Events

ARCHITECT BNP CALIBRATORSABBOTT GMBH2020-03-16
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9ORTHO-CLINICAL DIAGNOSTICS2020-02-20
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9ORTHO-CLINICAL DIAGNOSTICS2020-02-20
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9ORTHO-CLINICAL DIAGNOSTICS2020-02-20
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9ORTHO-CLINICAL DIAGNOSTICS2020-02-13
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2020-01-21
ARCHITECT BNP CALIBRATORSABBOTT GMBH2020-01-07
: ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-11-08
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-10-21
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-10-21
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-10-21
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-10-02
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-10-01
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-09-20
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-09-20
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-09-20
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-09-09
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-23
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-23
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-16
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-08-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-13
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-08-13
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-07
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-07
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-08-07
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-08-05
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-05
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-08-05
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-31
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-24
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-23
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-23
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-22
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-22
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-22
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-22
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-22
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-17
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-17
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-17
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-16
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-16
ARCHITECT BNP CALIBRATORSABBOTT GERMANY2019-07-15
ARCHITECT BNP CALIBRATORSABBOTT LABORATORIES2019-07-14
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