FDA UDI In Commercial Distribution 🇺🇸 United States

MAS Syphilis Positive Control

DI: 00884883007536 · Model: 10027483 · Microgenics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MAS Syphilis Positive Control
Primary DI
00884883007536
Version / Model
10027483
Company Name
Microgenics Corporation
Labeler DUNS
122153799
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-30
Public Version
1
Public Version Date
2020-07-08
Public Version Status
New
Public Device Record Key
302891b2-334e-4518-adeb-c217cb6a7c72

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
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
OHQ Multi-Analyte Controls Unassayed

GMDN Terms

Code Name
37733 Treponema pallidum total antibody IVD, control

Identifiers

Type ID
Primary 00884883007536