Carisoprodol Metabolite (Meprobamate) Enzyme Immun 0370

GUDID B07603700

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

LIN-ZHI INTERNATIONAL, INC.

Carisoprodol IVD, kit, enzyme immunoassay (EIA) Carisoprodol IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B07603700
• NIH Device Record Key: ea15d0d6-2ab7-494a-bf80-e6b6fbbd2ecb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carisoprodol Metabolite (Meprobamate) Enzyme Immun
• Version Model Number: 0370
• Catalog Number: 0370
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07603700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170010

FDA Product Code

• QBK: Meprobamate Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-19
• Device Publish Date: 2018-09-18

On-Brand Devices [Carisoprodol Metabolite (Meprobamate) Enzyme Immun]

• B07603710: Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
• B07603700: Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.