FDA.reportPublic FDA data

PRAS Columbia Blood Agar (CA)

Primary DI
00810048902354
Brand
PRAS Columbia Blood Agar (CA)
Company
ANAEROBE SYSTEMS
Model
AS-895
Catalog number
AS-895
Device description
AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048901166PrimaryGS10
00810048902354Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048901166008100489011668100489011660810048901166
00810048902354008100489023548100489023540810048902354

GMDN Terms#

Term, Definition table
TermDefinition
Enriched agar culture medium IVDAn agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-443-3108customerservice@anaerobesystems.com

Regulatory Flags#

DUNS number
021192653
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810048902460PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate AS-858AS-8582022-01-01
00810048902484PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)AS-846AS-8462022-01-01
00810048902507PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 (PYG TWEEN)AS-825AS-8252022-01-01
00810048900008PRAS Brucella Blood Agar (BRU)AS-111AS-1112020-05-01
00810048901470PRAS Brucelle Blood Agar (BRU)AS-141AS-1412020-05-01
00810048900022PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-112AS-1122020-05-01
00810048901487PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-142AS-1422020-05-01
00810048900046PRAS Bacteroides Bile Esculin Agar (BBE)AS-114AS-1142020-05-01
00810048901500PRAS Bacteroides Bile Esculin (BBE)AS-144AS-1442020-05-01
00810048900060PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-113AS-1132020-05-01
00810048901494PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-143AS-1432020-05-01
00810048901463PRAS Brucella Broth (BRU BROTH)AS-105AS-1052020-05-01
00810048900091PRAS Campylobacter Selective Agar (CAMPY)AS-211AS-2112020-05-01
00810048900107PRAS BBE/LKV BiplateAS-212AS-2122020-05-01
00810048901548PRAS BBE/LKV BiplateAS-242AS-2422020-05-01
00810048900121PRAS Cycloserine Cefoxitin Fructose Agar (CCFA) AS-213AS-2132020-05-01
00810048900138PRAS Cycloserine Cefoxitin Fructose Agar with Lysozyme (CCFA-L)AS-2133AS-21332020-05-01
00810048900145PRAS Cycloserine Cefoxitin Fructose Agar w/ Horse Blood & Taurocholate (CCFA-HT)AS-2136AS-21362020-05-01
00810048900152PRAS Chocolate Agar (CHOC)AS-214AS-2142020-05-01
00810048901555PRAS Chocolate Agar (CHOC)AS-244AS-2442020-05-01

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