RTCII 1st gen.

Basic Information

• Brand Name: RTCII 1st gen.
• Primary DI: 10694644200185
• Version / Model: 10-7BX2-030
• Catalog Number: 10-7BX2-030
• Company Name: AMERICAN BIO MEDICA CORPORATION
• Labeler DUNS: 966665036
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c1415996-9b24-4a67-8611-98560ba45d81

Device Description

3O+amp/bar/bzo/bup/op3 25/case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LAG	High Pressure Liquid Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	862.3870	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55455	Multiple therapeutic drugs/drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10694644200185	GS1
Unit of Use	10694644250180	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073078	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit