Barbiturate Enzyme Immunoassay 0140

GUDID B07601400

Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.

LIN-ZHI INTERNATIONAL, INC.

Barbiturate IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB07601400
NIH Device Record Key4a591c9d-ea33-4de8-afa6-88d38480b910
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarbiturate Enzyme Immunoassay
Version Model Number0140
Catalog Number0140
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 Usefalse
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07601400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DISEnzyme Immunoassay, Barbiturate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-24
Device Publish Date2016-07-05

On-Brand Devices [Barbiturate Enzyme Immunoassay]

B07601410Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
B07601400Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.

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