FDA.reportPublic FDA data

PRAS Porphyromonas gingivalis Agar (P.GING)

Primary DI
00810048900350
Brand
PRAS Porphyromonas gingivalis Agar (P.GING)
Company
ANAEROBE SYSTEMS
Model
AS-6422
Catalog number
AS-6422
Device description
AS-6422 Porphyromonas gingivalis Agar (P.GING) is an enriched selective medium used for the isolation and presumptive identification of Porphyromonas gingivalis. 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
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048900350PrimaryGS10
00810048901661Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048900350008100489003508100489003500810048900350
00810048901661008100489016618100489016610810048901661

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
021192653
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810048902477PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate AS-858AS-8582022-01-01
00810048902491PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)AS-846AS-8462022-01-01
00810048902514PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 (PYG TWEEN)AS-825AS-8252022-01-01
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
00810048900763PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG TWEEN FA/GLC)AS-825AS-8252020-05-01
00810048901135PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC)AS-846AS-8462020-05-01
00810048901142PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC AS-858AS-8582020-05-01
00810048900015PRAS Brucelle Blood Agar (BRU)AS-141AS-1412020-05-01
00810048900039PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-142AS-1422020-05-01
00810048900053PRAS Bacteroides Bile Esculin (BBE)AS-144AS-1442020-05-01
00810048900077PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-143AS-1432020-05-01
00810048900084PRAS Brucella Broth (BRU BROTH)AS-105AS-1052020-05-01
00810048900114PRAS BBE/LKV BiplateAS-242AS-2422020-05-01
00810048900169PRAS Chocolate Agar (CHOC)AS-244AS-2442020-05-01
00810048900176PRAS Botulism Selective Medium (BSM)AS-223AS-2232020-05-01
00810048900183PRAS Tryptic Soy Agar with Tween® and Lecithin (TSA-TL)AS-228AS-2282020-05-01
00810048900190PRAS Yeast Malt Extract Agar (YMEA)AS-229AS-2292020-05-01
00810048900213PRAS Tryptic Soy Blood Agar (TSBA)AS-542AS-5422020-05-01

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