Cambridge Biotech HIV-1 Urine Western Blot Kit 45000

GUDID 00864525000422

The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection.

BLUEJAY DIAGNOSTICS, INC.

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Primary Device ID00864525000422
NIH Device Record Keyb0001861-1b6d-4921-96f2-beb233c73e36
Commercial Distribution StatusIn Commercial Distribution
Brand NameCambridge Biotech HIV-1 Urine Western Blot Kit
Version Model Number01
Catalog Number45000
Company DUNS080412181
Company NameBLUEJAY DIAGNOSTICS, INC.
Device Count27
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com
Phone(844) 327-7078
Emailcontact@bluejaydx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100450000000027 [Unit of Use]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]
GS100864525000422 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by BLUEJAY DIAGNOSTICS, INC.

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00864525000422 - Cambridge Biotech HIV-1 Urine Western Blot Kit2020-06-23The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine specimens. This more specific assay is used as a supplemental test with urine specimens that tested repeatedly reactive using a screening procedure (Urine EIA Kit). The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection.
00864525000422 - Cambridge Biotech HIV-1 Urine Western Blot Kit2020-06-23 The Cambridge Biotech HIV-1 Urine Western Blot Kit is an in vitro qualitative assay for the detection and identification of anti
00864525000415 - Maxim HIV-1 Urine Enzyme Immunoassay2019-07-25 The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodefici

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