r2 Diagnostics Inc.

35 devices

Public registrations

3 cert. types · 35 public registrations

FDA 510(k)
CE-MDR
MHRA

Main field: Other
Main manufacturing country: US

Aggregated from registration data published by national regulators. It is not a count of currently valid certifications and may include expired or withdrawn records. Some registrations do not state a manufacturing country.

Products

Phospholin ES
In Vitro DiagnosticsMHRA
LupoTek KCT
In Vitro DiagnosticsMHRA
Emicizumab Calibrator
In Vitro DiagnosticsMHRA
Emicizumab Controls
In Vitro DiagnosticsMHRA
NOFACT IX
OtherFDA 510(k)
NOFACT VIII
OtherFDA 510(k)
LUPOTEK KCT
OtherFDA 510(k)
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
OtherFDA 510(k)
THROMBO TEK PSE, MODEL 90-480
OtherFDA 510(k)
PLASMACON N, PLASMACON L-1, PLASMACON L-2
OtherFDA 510(k)
T-TEK
OtherFDA 510(k)
FIBROTEK FIB
OtherFDA 510(k)
PHOSPHOPLASTIN RL
OtherFDA 510(k)
PHOSPHOLIN ES AND CALCIUM CHLORIDE
OtherFDA 510(k)
Emicizumab Calibrator
Other
EMICIZUMAB CALIBRATOR
Other
Emicizumab Controls
Other
EMICIZUMAB CONTROLS LEVEL 1 AND LEVEL 2
Other
FibroTek Fibrinogen kit
Other
LupoTek Correctin VL
Other
LupoTek Detectin VL
OtherCE-MDR
LupoTek KCT
Other
NoFact IX
Other
NoFact VIII
Other
Phospholin ES
Other
Phospholin ES
Other
Phosphoplastin RL
Other
Phosphoplastin RL
Other
PlasmaCon L1
Other
PlasmaCon L2
Other
PlasmaCon LA
Other
PlasmaCon N
OtherCE-MDR
ThromboTek PSe
Other
THROMBOTEK PSE (PROTEIN S ASSAY)
Other
T-Tek
Other