FDA UDI In Commercial Distribution 🇺🇸 United States

Maxwell® CSC RNA Blood Kit

DI: 00849811051739 · Model: AS1410 · PROMEGA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Maxwell® CSC RNA Blood Kit
Primary DI
00849811051739
Version / Model
AS1410
Catalog Number
AS1410
Company Name
PROMEGA CORPORATION
Labeler DUNS
089855696
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-02-01
Public Version
1
Public Version Date
2022-02-09
Public Version Status
New
Public Device Record Key
9fecad8d-1b22-40eb-ac36-410a3cb9e414

Device Description

The Maxwell® CSC RNA Blood Kit is a reagent kit used in combination with Maxwell® CSC instruments to perform automated isolation of RNA from whole human blood samples.

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
Yes
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
JJH Clinical Sample Concentrator

GMDN Terms

Code Name
52521 Nucleic acid extraction/isolation kit IVD

Identifiers

Type ID
Primary 00849811051739

Customer Contacts

Phone
608-839-7919

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
15 – 30 Degrees Celsius