FDA.reportPublic FDA data

OxyPRAS Plus 3-pack, Brucella, PEA, and KVL

Primary DI
00850056467100
Brand
OxyPRAS Plus 3-pack, Brucella, PEA, and KVL
Company
Oxyrase, Inc.
Model
M-BKP-3
Catalog number
M-BKP-3
Device description
Culture Media, Selective and Non-Differential
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSGCULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
JSJCULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056467100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056467100008500564671008500564671000850056467100

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight24Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(419)589-8800l.stewart@oxyrase.com

Regulatory Flags#

DUNS number
157281882
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056467124PEA OxyPlateO-PEA-BAO-PEA-BA2025-10-14
00850056467131OxyPRAS Plus StrictAna Blood Agar Plate with GentamycinP-SANA-BAP-SANA-BA2025-10-14
00850056467001OxyPRAS Plus Brucella Agar plateP-BRU-BAP-BRU-BA2023-11-30
00850056467018OxyPRAS Plus PEA PlateP-PEA-BAP-PEA-BA2023-11-30
00850056467025OxyPRAS Plus BBE/KVL Bi-PlateB-BCD-KVB-BCD-KV2023-11-30
00850056467032OxyPRAS Anaselect Blood Agar plateP-ANA-BAP-ANA-BA2023-11-30
00850056467049OxyPRAS Plus KVL plateP-KVL-BAP-KVL-BA2023-11-30
00850056467056OxyPRAS Plus Bile Esculin plateP-BBE-NBP-BBE-NB2023-11-30
00850056467063Schaedler Blood Agar OxyPlateO-SW-BAO-SW-BA2023-11-30
00850056467070KVL OxyPlateO-KVL-BAO-KVL-BA2023-11-30
00850056467087Modified Columbia Agar plateMCA-SMMCA-SM2023-11-30
00850056467094OxyPRAS Plus 3-pack: Brucella, PEA and BBE/KVL Bi-PlateM-BPBK-3M-BPBK-32023-11-30
00850056467117OxyPRAS Plus 2-pack, Brucella and BBE/KVL Bi-PlateM-BBK-2M-BBK-22023-11-30

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