Zer Hitech · 89-08 · ISRAEL
For Zer Hitech, import alert is 89-08; country is ISRAEL; 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 is HIV-I II One-Step Test and Quick AIDS Test | HIV-I II One-Step Test and Quick AIDS Test; product code is 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology; date published is 09/16/2009; address is 3, Shatner , Center , Jerusalem, ISRAEL, verified against its source on 2026-09-30.
- Firm
- Zer Hitech 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
- ISRAEL verified
- Address
- 3, Shatner , Center , Jerusalem, ISRAEL verified
- Date published
- 09/16/2009 verified
- Product code
- 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology each item verified
- Product
- HIV-I II One-Step Test and Quick AIDS Test | HIV-I II One-Step Test and Quick AIDS Test each item verified
- FDA notes
- HIV I and II One Step Tests 7/9/1998. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. 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. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution; and not for "research" or "investigation" uses as invoiced. 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 | 8/23/2001 | 8/23/2001 each item verified
What the source says
Zer Hitech Date Published : 09/16/2009 3, Shatner , Center , Jerusalem, ISRAEL
— 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, Product and FDA notes
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 01/30/2019 Notes: HIV I and II One Step Tests 7/9/1998. Several FDA districts have encountered shipments of unapproved test kits and labeled for "research use only" or "investigationa use only" and some of the kits were unlabeled. 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. Investigation by FDA revealed that the unapprived HIV diagnostic test kits were intended for commercial distribution; and not for "research" or "investigation" uses as invoiced. 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 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 01/30/2019 Desc: HIV-I II One-Step Test and Quick AIDS Test Notes: 8/23/2001 82 - - - -- Immunology Date Published: 01/30/2019 Desc: HIV-I II One-Step Test and Quick AIDS Test Notes: 8/23/2001
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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