FDA UDI In Commercial Distribution 🇺🇸 United States

ACCURUN EBV DNA Positive Control

DI: 00850041090139 · Model: 2020-0210 · Lgc Clinical Diagnostics, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
ACCURUN EBV DNA Positive Control
Primary DI
00850041090139
Version / Model
2020-0210
Company Name
Lgc Clinical Diagnostics, Inc.
Labeler DUNS
106267123
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-11-21
Public Version
1
Public Version Date
2025-12-01
Public Version Status
New
Public Device Record Key
378e855f-4b02-4fd8-a3bc-2a0bb827477f

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
49653 Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Identifiers

Type ID
Primary 00850041090139