CAMPY (jcl) Latex 50 Test Kit

Basic Information

• Brand Name: CAMPY (jcl) Latex 50 Test Kit
• Primary DI: 00813545026288
• Version / Model: L-CAM01T
• Catalog Number: L-CAM01T
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0a1509bf-338d-4f2e-a4b6-afd99a276954

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
LQP	Campylobacter Spp.	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50678	Multiple Campylobacter species culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from one or multiple species of Campylobacter bacteria isolated by culture from a clinical specimen, using an agglutination method. Species of Campylobacter bacteria detected may include C. coli, C. fetus and/or C. jejuni.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545026288	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K880389	000