FDA UDI In Commercial Distribution 🇺🇸 United States

IL-6 AccuLite CLIA Test System - 96 Wells

DI: 00816870023977 · Model: 13275-300 · MONOBIND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
IL-6 AccuLite CLIA Test System - 96 Wells
Primary DI
00816870023977
Version / Model
13275-300
Catalog Number
13275-300A
Company Name
MONOBIND, INC.
Labeler DUNS
083155515
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-09-13
Public Version
1
Public Version Date
2024-09-23
Public Version Status
New
Public Device Record Key
3ce2ef09-cbfa-45e6-b3d6-f2d42686ce65

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QLC Interleukin 6

GMDN Terms

Code Name
53863 Interleukin-6 receptor (IL-6r) IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 00816870023977

Customer Contacts

Device Sizes

Type Value Unit Text
Width 7.75 Inch

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius