ELITECH GROUP INC.

Address:370 West 1700 South,LOGAN,UT,84321,US

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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

Internal Polymerase Chain Reaction Control, Not Assay Specific (OLD) (3)

Premarket Exempt

Yes

Clear

MGB Alert Internal Control Set IC2-C -480 rxn QTY-25 - 03661540952296 Catalog Number : 800432-25

Device Description : The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an un-assayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. QTY-25@480 reactions.

Device Class : 1

Duns Number: 079696864

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

MGB Alert Internal Control Set IC2-C -480 rxn QTY-100 - 03661540952302 Catalog Number : 800432-100

Device Description : The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. QTY-100@480 reactions.

Device Class : 1

Duns Number: 079696864

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

MGB Alert IC1 Internal Control Template (35uL volume) - 03661540952371 Catalog Number :

Device Description : The MGB Alert Internal Control Set IC1 consists of reagents intended for use as The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an un-assayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.

Device Class : 1

Duns Number: 079696864

Premarket Exempt : Yes

Product Code : OLD

Prescription Use : No

Device Count : 1

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