FDA.report

PRAS Campylobacter-Wolinella Differential Medium (CAMPY-WOL)

Primary DI
00810048901647
Brand
PRAS Campylobacter-Wolinella Differential Medium (CAMPY-WOL)
Company
ANAEROBE SYSTEMS
Model
AS-6420
Catalog number
AS-6420
Device description
AS-6420 Campylobacter-Wolinella Differential Medium (CAMPY-WOL) is an enriched, selective, and differential media used for the isolation and presumptive identification of anaerobic Campylobacter species. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow/green. 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

Related Records

Contact Domains

Product Codes

CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810048901340PrimaryGS10
00810048901647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048901340008100489013408100489013400810048901340
00810048901647008100489016478100489016470810048901647

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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