Buprenorphine Enzyme Immunoassay 08362955190

GUDID 00850624008018

200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850624008018
NIH Device Record Key0fd06983-f9ee-421d-862d-f9e952f06720
Commercial Distribution StatusIn Commercial Distribution
Brand NameBuprenorphine Enzyme Immunoassay
Version Model Number08362955190
Catalog Number08362955190
Company DUNS840839190
Company NameLIN-ZHI INTERNATIONAL, INC.
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850624008018 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-15
Device Publish Date2018-04-20

On-Brand Devices [Buprenorphine Enzyme Immunoassay]

008693350002042 x 100 Test Kit. Antibody/Substrate Reagent (R1): 2 x 20 mL. Enzyme Conjugate Reagent (R2): 2 x
00850624008018200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.
B07602710Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
B07602700Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
00850624008513240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reage

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