Reference Source

Globus Media · 89-08 · CANADA

For Globus Media · 89-08 · CANADA, 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 CANADA; product code is 57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 75 - - - -- Chemistry | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 81 - - - -- Hematology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 88 - - - -- Pathology | 89 - - - -- Physical Medicine | 90 - - - -- Radiology | 91 - - - -- Toxicology | 92 - - - -- Molecular Genetics; date published is 09/16/2009; address is 9390 Pie-Ix Blvd , Montreal, Quebec CANADA, verified against its source on 2026-09-16.

Firm
Globus Media 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
CANADA verified
Address
9390 Pie-Ix Blvd , Montreal, Quebec CANADA verified
Date published
09/16/2009 verified
Product code
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 75 - - - -- Chemistry | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 81 - - - -- Hematology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 88 - - - -- Pathology | 89 - - - -- Physical Medicine | 90 - - - -- Radiology | 91 - - - -- Toxicology | 92 - - - -- Molecular Genetics each item verified
FDA notes
All medical devices. GPI = DE, DI, BI, SD. 2/9/2005. The firm is known to have shipped and/or marketed the following products in the US Rapid HIV Test Kit, Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette Style Cocaine Test Kit, Class II device, One Step Cassette Style Marijuana THC Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class II Device, Rapid Dangue Fever Test Kit Class III device, One Step Midstream style HCG Urine Home Pregnancy Test Kit, Class III device. If districts encounter shipments of any device from the above shipper/markerting firm, contact DIOP attn Sammi Hadden 301-827-9632 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Globus Media Date Published : 09/16/2009 9390 Pie-Ix Blvd , Montreal, Quebec CANADA 57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag Date Published: 01/30/2019 73 - - - -- Anesthesiology Date Published: 09/16/2009 Notes: All medical devices. GPI = DE, DI, BI, SD. 2/9/2005. The firm is known to have shipped and/or marketed the following products in the US Rapid HIV Test Kit, Class III device, Rapid Syphilis Test Kit, Class III Device, One Step Casette Style Cocaine Test Kit, Class II device, One Step Cassette Style Marijuana THC Test Kit, Class II device, One Step Cassette Style Amphetamine Test Kit, Class II Device, Rapid Dangue Fever Test Kit Class III device, One Step Midstream style HCG Urine Home Pregnancy Test Kit, Class III device. If districts encounter shipments of any device from the above shipper/markerting firm, contact DIOP attn Sammi Hadden 301-827-9632 74 - - - -- Cardiovascular Date Published: 09/16/2009 75 - - - -- Chemistry Date Published: 01/30/2019 76 - - - -- Dental Date Published: 09/16/2009 77 - - - -- Ear,Nose And Throat Date Published: 09/16/2009 78 - - - -- Gastroenterological & Urological Date Published: 09/16/2009 79 - - - -- General & Plastic Surgery Date Published: 09/16/2009 80 - - - -- General Hospital/Personal Use Date Published: 09/16/2009 81 - - - -- Hematology Date Published: 01/30/2019 82 - - - -- Immunology Date Published: 01/30/2019 83 - - - -- Microbiology Date Published: 01/30/2019 84 - - - -- Neurological Date Published: 09/16/2009 85 - - - -- Obstetrical & Gynecological Date Published: 09/16/2009 86 - - - -- Ophthalmic Date Published: 09/16/2009 87 - - - -- Orthopedic Date Published: 09/16/2009 88 - - - -- Pathology Date Published: 01/30/2019 89 - - - -- Physical Medicine Date Published: 09/16/2009 90 - - - -- Radiology Date Published: 09/16/2009 91 - - - -- Toxicology Date Published: 01/30/2019 92 - - - -- Molecular Genetics Date Published: 01/30/2019

— accessdata.fda.gov, retrieved 2026-09-15

Source

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