MGB Alert IC1 Internal Control Template (35uL volume)

FDA UDI

Class I (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: MGB Alert IC1 Internal Control Template (35uL volume) FDA UDI
Generic Name: Exogenous DNA/RNA internal control IVD, kit FDA UDI
Device Name: 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. FDA UDI
Model / Reference: M800735 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 03661540952371 FDA UDI
FDA Product Code: OLD FDA UDI
GMDN Term: Exogenous DNA/RNA internal control IVD, kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Exogenous DNA/RNA internal control IVD, kit

MGB Alert IC1 Internal Control Template (35uL volume) by Elitechgroup Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI 53e42fca-b0ae-4a97-b4a5-415f1c1cfef1 35 fields · synced May 30, 2026