PMDA device listing
オンコマインTM Dx Target Test マルチ CDxシステム（テンプレート調製試薬）
PMDA Medical device listing · 23000BZX00089000 · Class III
Key facts
| PMDA document key | 840863_23000BZX00089000_B_01 |
|---|---|
| Brand names | オンコマインTM Dx Target Test マルチ CDxシステム（テンプレート調製試薬） |
| General names (JMDN) | 体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用） |
| Product type | Medical device |
| Device class (Japan) | Class III |
| Approval, certification or notification number | 23000BZX00089000 |
| JMDN codes | 71059003 |
| Category code | A1700 |
| Marketing authorization holder | 製造販売／〈製造販売業者〉ライフテクノロジーズジャパン株式会社 |
| Package insert date | Sep 11, 2026 |
| Latest revision | 2026-09 |
| PMDA product page | pmda.go.jp |
| Package insert on pmda.go.jp | pmda.go.jp |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- Listed Listed on the PMDA site
- Yes 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: