Primary Device ID | 00864525000422 |
NIH Device Record Key | b0001861-1b6d-4921-96f2-beb233c73e36 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cambridge Biotech HIV-1 Urine Western Blot Kit |
Version Model Number | 01 |
Catalog Number | 45000 |
Company DUNS | 080412181 |
Company Name | BLUEJAY DIAGNOSTICS, INC. |
Device Count | 27 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
00864525000408 - Allereye® Tear Total IgE Test Kit | 2020-06-23 Allereye® is a rapid immunoassay for the detection of total IgE in tears. |
00864525000422 - Cambridge Biotech HIV-1 Urine Western Blot Kit | 2020-06-23The 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 Kit | 2020-06-23 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 Immunoassay | 2019-07-25 The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodefici |