What is FDA product code PPM?

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

NeuMoDxTM Lysis Buffer 4 · General Purpose Reagent → Hematology

Name: NeuMoDxTM Lysis Buffer 4
Brand: NeuMoDxTM Lysis Buffer 4

30manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PPM
Manufacturer	City	Province	Registered as	Device types
Takara Biotechnology (Dalian) Co., Ltd.	Dalian	Liaoning	Contract manufacturer	1
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Zhejiang Gene Science Co., Ltd.	Shaoxing	Zhejiang	Manufacturer	31
Biomed Plastics Co.	Taicang	Jiangsu	Contract manufacturer	29
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25
AVE Science & Technology Co., Ltd.	Changsha	Hunan	Manufacturer	22
Bioteke Corporation (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Manufacturer	21
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17
Shanghai FLY Medical Devices Co., Ltd.	Minhang District	Shanghai	Manufacturer	15
Medico Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11

Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent

Record

Regulatory record for NeuMoDxTM Lysis Buffer 4
Listed by	Neumodx Molecular, Inc., United States
FDA product code	PPM
Device type	General Purpose Reagent
Device class	Class 1
Regulation	21 CFR 864.4010
Record published	2019-03-29
Record revised	2025-08-08 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment humidity 20 to 60 % RH; Handling environment humidity 20 to 60 % RH; Storage environment temperature 18 to 28 °C; Handling environment temperature 18 to 28 °C
Sizes	Total volume 100 ml
Distribution end date	2025-08-07
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for NeuMoDxTM Lysis Buffer 4
Catalogue number	Size	Per pack	Status
400700	Total Volume 100 ml	4	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Diagnostic BioSystems	Diagnostic Biosystems	62
Epredia	Richard-Allan Scientific LLC	59
Alpha-Tec Systems	Alpha-Tec Systems, Inc.	46
Vysis	Abbott Molecular, Inc.	34
Genemed®	Sakura Finetek U.S.A., Inc.	33
Edge Biologicals Inc	Edge Biologicals, Inc.	25
Immunalysis	Immunalysis Corporation	22
Fisherbrand	Fisher Scientific Company L.L.C.	22
Bond	Leica Biosystems Newcastle Ltd	16
Vitros	Ortho-Clinical Diagnostics, Inc.	16
Synchron	Beckman Coulter, Inc.	13
Immy	Immuno-Mycologics, Inc.	12

Showing 12 of 617. All products under General Purpose Reagent

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-05-24	Class II	Employee error	Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics perf	20,016 cartridges

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

NeuMoDxTM Lysis Buffer 4