List of Approved COVID-19 Rapid Antibody Test Kits
The FDA-Philippines issued Advisory No. 483-20 on March 30, 2020, which provides an initial list of approved COVID-19 Rapid Antibody Test Kits as part of the country's response to the pandemic. The advisory lists specific products and their manufacturers, including those from Biolidics Limited and various companies from China. The FDA emphasizes that this list will be regularly updated to reflect new approvals. Additionally, the public is encouraged to report any sales or distribution of unapproved test kits via email.
Law Information
- Reference Number
- FDA Advisory No. 483-20
- Date Enacted
- Subcategory
- Food and Drugs Administration of the Philippines
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
March 30, 2020
FDA ADVISORY NO. 483-20
| TO | : | The General Public |
| SUBJECT | : | List of Approved COVID-19 Rapid Antibody Test Kits |
In line with the ongoing response to the increasing number of COVID-19 cases in the Philippines, the Food and Drug Administration (FDA)-Philippines hereby provides an initial list of approved Rapid Antibody Test Kits. HEITAD
|
|
PRODUCT NAME |
MANUFACTURER |
|
1. |
NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT |
Biolidics Limited — 37 Jalan Pemimpin, #02-07, Mapex, Singapore |
|
2. |
NOVEL CORONA VIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) |
Nanjing Vazyme Medical Technology Co., Ltd. — Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China |
|
3. |
DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) |
Zhuhai Livzon Diagnostic, Inc. — 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People's Republic of China |
|
4. |
2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) |
Innovita (Tangshan) Biological Technology Co., Ltd. — No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian'an 064400, Hebei, China |
|
5. |
SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD) |
Guangzhou Wondfo Biotech Co., Ltd. — No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People's Republic of China |
This list shall be regularly updated. For reference please click the link. https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez
To report any sale or distribution of COVID-19 rapid test kits not included in the list, you may email us at [email protected].
(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General
Cite This Law
List of Approved COVID-19 Rapid Antibody Test Kits, FDA Advisory No. 483-20, Mar 30, 2020 (Philippines)
List of Approved COVID-19 Rapid Antibody Test Kits, FDA Advisory No. 483-20 (Phil. 2020)
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