Sundries Network International Ltd. · 89-08 · HONG KONG SAR
For Sundries Network International Ltd., import alert is 89-08; country is HONG KONG SAR; 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)"; product code is 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology; date published is 09/16/2009; address is 300-306 Lockhart Road , Flat B, 4/F, Kiu Fu Comm. Building , Chai Wan, HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Sundries Network International Ltd. verified
- 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
- HONG KONG SAR verified
- Address
- 300-306 Lockhart Road , Flat B, 4/F, Kiu Fu Comm. Building , Chai Wan, HONG KONG SAR verified
- Date published
- 09/16/2009 verified
- Product code
- 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology each item verified
- FDA notes
- OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. | OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. each item verified
What the source says
Sundries Network International Ltd. Date Published : 09/16/2009 300-306 Lockhart Road , Flat B, 4/F, Kiu Fu Comm. Building , Chai Wan, HONG KONG SAR
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 09/16/2009 Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. 82 - - - -- Immunology Date Published: 09/16/2009 Notes: OC's HIV - 1/2 Antibody HIV1/2 Whole Blood One Step Test 9/19/2001. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.