PMDA device listing
コバス試薬 BIL-D Gen.2(コバス システム-G)
PMDA In vitro diagnostic listing · 302AAEZX00054000 · Class II
Key facts
| PMDA document key | 700025_302AAEZX00054000_B_02 |
|---|---|
| Brand names | コバス試薬 BIL-D Gen.2(コバス システム-G) |
| General names (JMDN) | 直接ビリルビンキット |
| Product type | In vitro diagnostic |
| Device class (Japan) | Class II |
| Approval, certification or notification number | 302AAEZX00054000 |
| JMDN codes | 30157012 |
| Category code | A0100 |
| Marketing authorization holder | 製造販売／ロシュ・ダイアグノスティックス株式会社 |
| Package insert date | Dec 14, 2022 |
| Latest revision | 2022-08 |
| 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: