FDA UDI In Commercial Distribution 🇺🇸 United States

hsCRP Wide Range Reagent

DI: 00817238011056 · Model: 85550 · CLINIQA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
hsCRP Wide Range Reagent
Primary DI
00817238011056
Version / Model
85550
Company Name
CLINIQA CORPORATION
Labeler DUNS
078742335
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-23
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
28dbbdb4-cdd9-475a-82a9-470a4938ff2c

Device Description

hsCRP Wide Range Reagent

Device Characteristics

Single Use
No
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
DCK C-Reactive Protein, Antigen, Antiserum, And Control

GMDN Terms

Code Name
53707 C-reactive protein (CRP) IVD, reagent

Identifiers

Type ID
Primary 00817238011056