FDA UDI In Commercial Distribution 🇺🇸 United States

ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)

DI: 05055273200119 · Model: AE1032 · RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)
Primary DI
05055273200119
Version / Model
AE1032
Company Name
RANDOX LABORATORIES LIMITED
Labeler DUNS
227530649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-31
Public Version
2
Public Version Date
2020-12-21
Public Version Status
Update
Public Device Record Key
b34a988a-0fb5-42df-a29b-2fcdea8c568c

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
JJY Multi-Analyte Controls, All Kinds (Assayed)

GMDN Terms

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

Identifiers

Type ID
Primary 05055273200119