Primary Device ID | 00628451188056 |
NIH Device Record Key | e87950af-1c26-44a2-9ca4-f578f340b4af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reveal G4 Rapid HIV-1 Antibody Test |
Version Model Number | 815311007583 |
Company DUNS | 243757049 |
Company Name | MedMira Laboratories Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628451188056 [Primary] |
MZF | Test, Hiv Detection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-30 |
00628451188070 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |
00628451188063 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |
00628451188056 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |
10628451188138 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |
10628451188121 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |
10628451188114 | Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to det |