FDA UDI In Commercial Distribution 🇺🇸 United States

PRAS Brucella Agar Deep CLSI Formulation 17mL (BRU DEEP CLSI 17mL)

DI: 00810048901388 · Model: AS-809 · ANAEROBE SYSTEMS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

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Basic Information

Brand Name
PRAS Brucella Agar Deep CLSI Formulation 17mL (BRU DEEP CLSI 17mL)
Primary DI
00810048901388
Version / Model
AS-809
Catalog Number
AS-809
Company Name
ANAEROBE SYSTEMS
Labeler DUNS
021192653
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2020-05-01
Public Version
1
Public Version Date
2020-05-11
Public Version Status
New
Public Device Record Key
3c48ae76-3608-4679-937e-5921d8263e5c

Device Description

AS-809 Brucella Agar Deep CLSI 17 mL (BRU DEEP CLSI 17mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 17 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
JSG Culture Media, Non-Selective And Non-Differential

GMDN Terms

Code Name
58685 Basic/simple nutrient agar culture medium IVD

Identifiers

Type ID
Unit of Use 00810048901883
Primary 00810048901388

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
20 – 25 Degrees Celsius