FDA UDI In Commercial Distribution 🇺🇸 United States

BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3)

DI: 05055273206173 · Model: SE1086 · RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3)
Primary DI
05055273206173
Version / Model
SE1086
Company Name
RANDOX LABORATORIES LIMITED
Labeler DUNS
227530649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-03
Public Version
2
Public Version Date
2020-12-21
Public Version Status
Update
Public Device Record Key
ea075c6f-2706-4299-b473-dc4dab5c95c5

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
OHQ Multi-Analyte Controls Unassayed

GMDN Terms

Code Name
47869 Multiple-type clinical chemistry analyte profile IVD, control

Identifiers

Type ID
Primary 05055273206173