FDA UDI In Commercial Distribution 🇺🇸 United States

EliA CCP Positive Control 2500/5000

DI: 07333066020020 · Model: 83-0008-81 · Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
EliA CCP Positive Control 2500/5000
Primary DI
07333066020020
Version / Model
83-0008-81
Catalog Number
83-0008-81
Company Name
Phadia AB
Labeler DUNS
354019424
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-03-29
Public Version
2
Public Version Date
2023-12-11
Public Version Status
Update
Public Device Record Key
5da97d73-47b9-4487-a9f3-88698c45723f

Device Description

EliA CCP Positive Control 2500/5000

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

GMDN Terms

Code Name
30506 Plasma protein IVD, control

Identifiers

Type ID
Package 07333066014173
Primary 07333066020020

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius