FDA.reportPublic FDA data

Schaedler Blood Agar OxyPlate

Primary DI
00850056467063
Brand
Schaedler Blood Agar OxyPlate
Company
Oxyrase, Inc.
Model
O-SW-BA
Catalog number
O-SW-BA
Device description
Culture Media, Enriched
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
KZICULTURE MEDIA, ENRICHED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056467063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056467063008500564670638500564670630850056467063

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.

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
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
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
00850056467100OxyPRAS Plus 3-pack, Brucella, PEA, and KVLM-BKP-3M-BKP-32023-11-30
00850056467117OxyPRAS Plus 2-pack, Brucella and BBE/KVL Bi-PlateM-BBK-2M-BBK-22023-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911144RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
05051716000162AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398020558N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398028431N/AHARDY DIAGNOSTICSKZI2020-09-02
00816576027576N/AHARDY DIAGNOSTICSKZI2020-06-08
00816576027613N/AHARDY DIAGNOSTICSKZI2020-06-08
00819398024228HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024242HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024266HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024235HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00816576027262N/AHARDY DIAGNOSTICSKZI2020-06-05
00816576027477N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023535N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023528N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398022194N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022293N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398028127N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022187N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022286N/AHARDY DIAGNOSTICSKZI2020-06-03