14 results
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37ms
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Sources: EU EUDAMED, US FDA
VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Recall
Terminated
·Cellestis Inc·Product code NCD·September 27, 2012
Vacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Recall
Terminated
·Cellestis Inc·Product code NCD·September 27, 2012
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC.·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC.·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS, INC.·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC.·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC·Product code NCD·February 3, 2016
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC.·Product code NCD·February 3, 2016
UNK
FDA Adverse Event
Injury
·CELLESTIS INC·Product code NCD·July 10, 2013
Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Enforcement
Class II
·Terminated·Cellestis Inc·March 6, 2013
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Enforcement
Class II
·Terminated·Cellestis Inc·March 6, 2013