Primary Device ID | B07603910 |
NIH Device Record Key | adde9da6-f6a6-4748-b5f9-f30746443f70 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hydrocodone 300 Enzyme Immunoassay |
Version Model Number | 0391 |
Catalog Number | 0391 |
Company DUNS | 840839190 |
Company Name | LIN-ZHI INTERNATIONAL, 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 | true |
Device Combination Product | false |
Single Use | false |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B07603910 [Primary] |
DJG | Enzyme Immunoassay, Opiates |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2018-10-15 |
Device Publish Date | 2016-07-05 |
B07603910 | Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. |
B07603900 | Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL. |