N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00850041798042
• Version / Model: K982375
• Company Name: Key Scientific Products Incorporated
• Labeler DUNS: 783601115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 2
• Public Version Date: 2023-11-10
• Public Version Status: Update
• Public Device Record Key: 31a9d8a1-95ce-44bf-afa4-a8c65ce6313d

Device Description

Pep ReagentT

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
43720	Indole/Kovac's microbial reagent IVD	A substance or reactant, sometimes referred to as indole reagent or Kovac's reagent, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850041798042	GS1
Package	10850041798049	GS1	Box	1	In Commercial Distribution