PMDA device listing

マイクロスキャン Rapid Plus Neg II シリーズ ID4

PMDA In vitro diagnostic listing · 21800AMX10890000 · Class III

Key facts

PMDA document key 700016_21800AMX10890000_B_02
Brand names マイクロスキャン Rapid Plus Neg II シリーズ ID4
General names (JMDN) クラスIII細菌検査用シリーズ
Product type In vitro diagnostic
Device class (Japan) Class III
Approval, certification or notification number 21800AMX10890000
JMDN codes 80016003
Category code A0100
Marketing authorization holder 製造販売/ベックマン・コールター株式会社
Package insert date Mar 10, 2015
Latest revision 2015-03
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)