FDA UDI In Commercial Distribution 🇺🇸 United States

BRUCELLA ABORTUS ANTISERUM

DI: 00695684011000 · Model: 1100 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BRUCELLA ABORTUS ANTISERUM
Primary DI
00695684011000
Version / Model
1100
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-12
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
656751b1-042d-482d-88d9-d765655a067e

Device Description

Brucella Abortus Antiserum is intended for use as control material for Brucella antigens.

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
GSM Antisera, Fluorescent, Brucella Spp.

GMDN Terms

Code Name
32502 Multiple febrile infection-associated bacteria antigen IVD, control

Identifiers

Type ID
Primary 00695684011000