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Abbott Diagnostics Medical TestPack Plus Strep A with On Board Controls (OBC) - HSA Registration DE0507030

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.

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CLASS B IVD
DE0507030
Abbott Diagnostics Medical TestPack Plus Strep A with On Board Controls (OBC)
HSA Registration Number: DE0507030
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Product Description

TestPack Plus Strep A with On Board Controls (OBC) is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep) antigen from throat swab specimens as an aid to the diagnosis of Group A Strep pharyngitis or for culture confirmation. For professional in vitro diagnostic use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0507030
Registration Date
June 29, 2022
Change Notification Approval Date
April 15, 2025
Retention Due Date
June 28, 2025
Product Owner
Short Name
Abbott Diagnostics Medical Co., Ltd.
Address
357 Matsuhidai, Matsudo-shi,, Chiba 270-2214,, JAPAN
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model Information
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