Abbott Diagnostics Medical TestPack Plus Strep A with On Board Controls (OBC)
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
- Registration Number
- DE0507030
- Registration Date
- June 29, 2022
- Change Notification Approval Date
- April 15, 2025
- Retention Due Date
- June 28, 2025
- Short Name
- Abbott Diagnostics Medical Co., Ltd.
- Address
- 357 Matsuhidai, Matsudo-shi,, Chiba 270-2214,, JAPAN
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
- Model Name(s)
- PACKAGE INSERT Testpack Plus Strep A with OBC Testpack Plus Strep A with OBC STERILE POLYESTER (DACRON) TIPPED SWAB EXTRACTION TUBES REAGENT 1 (5 mL) REAGENT 2 (5 mL) REAGENT 3 (5 mL) REAGENT 1 (10mL) REAGENT 2 (10mL) REAGENT 3 (10mL) REACTION DISCS
- Model Identifier(s)
- 240599/R4 505715J 505796J F2340 F2344 G2305 G2306 G2307 G2308 G2309 G2310 J2218B
Access comprehensive regulatory information for Abbott Diagnostics Medical TestPack Plus Strep A with On Board Controls (OBC) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0507030 and owned by Abbott Diagnostics Medical Co., Ltd.. The device was registered on June 29, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.