US Agent Collection Oral Fluid Kit

GUDID 00850054552013

US Agent Collection Oral Fluid Kit

Quest Diagnostics

Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated Specimen container mailer, insulated

• Primary Device ID: 00850054552013
• NIH Device Record Key: e552ab69-d8c3-4988-89a7-235545979639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Agent Collection Oral Fluid Kit
• Version Model Number: Exempt
• Company DUNS: 189222334
• Company Name: Quest Diagnostics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054552013 [Primary]
GS1	10850054552010 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20850054552017 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	30850054552014 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	40850054552011 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• KDT: Container, Specimen Mailer And Storage, Sterile

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: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by Quest Diagnostics

• 10850054552034 - US Blood And Urine Kit: 2024-05-09 US Blood And Urine Kit
• 10850054552041 - US Paramed Collection Oral Fluid Kit: 2024-05-09 US Paramed Collection Oral Fluid Kit
• 10850054552058 - US Urine Examiner Kit: 2024-05-09 US Urine Examiner Kit
• 00850054552013 - US Agent Collection Oral Fluid Kit: 2024-01-23US Agent Collection Oral Fluid Kit
• 00850054552013 - US Agent Collection Oral Fluid Kit: 2024-01-23 US Agent Collection Oral Fluid Kit
• 00869419000298 - Multi Use 9 drug (CASE): 2024-01-01 Multi Use 9 drug (CASE)
• 00810121520000 - Blood Specimen Collection Kit (EPH): 2023-08-31 The Tasso+ Kit is a kit that includes the Tasso+ device and all supplies necessary to collect a blood sample. The Tasso+ device
• 00868586000261 - HairCheck-DT (THC) Exempt: 2023-07-19 HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of ha
• 00868586000285 - General Purpose Reagent Delayed Semen Analysis Media: 2023-07-19 DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analys