Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit

FDA UDI

Class I (US FDA UDI)

by Promega Corporation

Identity

Trade Name: Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: Lysis buffer used to lyse cells for nucleic acid extraction. FDA UDI
Model / Reference: 02N77-01 FDA UDI
Description: Lysis buffer used to lyse cells for nucleic acid extraction. FDA UDI

Identifiers

Catalog Number: 02N77-01 FDA UDI
Primary DI / UDI-DI: 00849811004636 FDA UDI
FDA Product Code: PPM FDA UDI
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit by Promega Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Nucleic acid extraction/isolation kit IVD.

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MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

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: Promega Corporation

Sources (1)

FDA UDI 43145694-c6a6-40a1-be25-cabb07d3c8df 36 fields · synced Jun 9, 2026