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.

Hematology › Specimen Preparation ReagentsGeneral Purpose Reagent

Ultraview Sish DNP Detection Kit

Name: ultraView Sish DNP Detection Kit
Brand: ultraView Sish DNP Detection Kit

Catalogue number 100 tests, listed by Ventana Medical Systems, Inc., United States, under General Purpose Reagent. 30 manufacturers in China are registered for this product code.

Registry build 21.09.26

30manufacturers in China registered for this device type

1catalogue number

6recalls on this code

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 ultraView Sish DNP Detection Kit
Listed by	Ventana Medical Systems, Inc., United States
FDA product code	PPM
Device type	General Purpose Reagent
Device class	Class 1
Regulation	21 CFR 864.4010
Establishment	Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2014-09-12
Record revised	2025-12-12 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for ultraView Sish DNP Detection Kit
Catalogue number	Size	Status
100 tests		In distribution

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 Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of ultraView Sish DNP Detection Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Ventana Medical Systems, Inc.	UDI-DI	2017-12-19	Class I	Process control	Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.	20 units	2021-11-22

Recalls

5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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	Closed
2018-08-02	Class I	Under Investigation by firm	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers	559 units	2021-11-22
2018-08-02	Class I	Under Investigation by firm	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.	342 units	2021-11-22
2018-08-02	Class I	Under Investigation by firm	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.	2136 units	2021-11-22
2017-12-19	Class I	Process control	Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.	6 units	2021-11-22
2017-12-19	Class I	Process control	Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.	358 units	2021-11-22

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.