LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Address:7 Gul Circle, #2M-01/08,Jurong West North West,SG

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

real time Nucleic acid amplification system (OOI) (9) Instrumentation for clinical multiplex test systems (NSU) (1)

Premarket Exempt

No Yes

Clear

7500 Fast Dx Real-Time PCR Instrument - 10190302000222 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

384-Well Region of Interest and Background Plates - 10190302000314 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Rnase P Fast 384-Well Instrument Verification Plate - 10190302000321 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

RNase P 96-Well Instrument Verification Plate - 10190302000369 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Fast 96-Well Spectral Calibration Plate with FAM™ Dye - 10190302000376 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Fast 96-Well Spectral Calibration Plate with VIC™ Dye - 10190302000383 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Fast 96-Well Spectral Calibration Plate with ROX™ Dye - 10190302000390 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

96-Well Region of Interst and Background Plates - 10190302000413 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Fast 96-Well Spectral Calibration Plate with TAMRA™ Dye - 10190302000420 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Fast 96-Well Region of Interest (ROI) and Background Plates - 10190302000437 Catalog Number :

Device Class : 2

Duns Number: 628548377

Premarket Exempt : No

Product Code : OOI

Prescription Use : Yes

Device Count : 1

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