# Shanghai Meikang Biological Project Co. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shanghai Meikang Biological Project Co. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is All IVD Tests | All IVD Tests | All IVD Tests; product code is 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin | 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter | 83 G - - TY Antigens, All Groups, Streptococcus Spp; date published is 01/07/2011; address is No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA, verified against its source on 2026-09-16.

- **Firm:** Shanghai Meikang Biological Project Co. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA _(verified: appears in the quote below)_
- **Date published:** 01/07/2011 _(verified: appears in the quote below)_
- **Product code:** 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin | 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter | 83 G - - TY Antigens, All Groups, Streptococcus Spp. _(verified: each item appears in the quote below)_
- **Product:** All IVD Tests | All IVD Tests | All IVD Tests _(verified: each item appears in the quote below)_
- **FDA notes:** 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE | 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE | 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE _(verified: each item appears in the quote below)_

## What the source says

> Shanghai Meikang Biological Project Co. Date Published : 01/07/2011 No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE 83 G - - TY Antigens, All Groups, Streptococcus Spp. Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).