PRECISION SYSTEM SCIENCE COMPANY LIMITED Odate Reagent Center
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Präzisionssystemwissenschaft Co., Ltd
Precision System Science Co., Ltd. (PSS) trägt zum Fortschritt von Biotechnologie und Medizin durch die Entwicklung und Lieferung von Geräten bei, die die Automatisierung jedes Arbeitsprozesses in der molekularen Diagnose vorantreiben, einem zentralen Thema in der biomedizinischen Forschung und Entwicklung.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Odate-shi Akita, Japan
- Website
- https://pss.co.jp
- Categories
- Medizin- & Gesundheitsbedarf
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 4 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-08-14. FDA
- Registry ID checks out with the state register (record type: registry-link-unconfirmed) [official record; status amber] A register record with this number exists, but its link to this company is not established: the registered name or address does not confirm it. checked 2026-09-22. gBizINFO (Ministry of Economy, Trade and Industry), government-held corporate data
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-14. FDA
- Registered with the market regulator: United States (record type: market-access-us) [official record; status green] Shows the facility is on the destination market's list of establishments approved for the listed goods. A listing is not an observation of current production. checked 2026-08-23. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-14. Mail server of the company domain
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-14. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-14. OpenSanctions
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-08-07. US FDA device establishment registration (openFDA)
Relationships
1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- Real Time Nucleic Acid Amplification System: Products on the register. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- US: Approved for this market, country US. FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
Candidates, not confirmed
- pss.co.jp: Website of this business. Source record
Import rules for these goods
Product-specific import rules not established for the catalog category Medizin- & Gesundheitsbedarf: neither the company's own description nor an official activity code shows that its own goods are of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.