Duns Number:039981550
Device Description: BCYE Agar / BCYE Agar without Cysteine, 15x100mm Biplate, 12ml/12ml. Hardy Diagnostics Buf BCYE Agar / BCYE Agar without Cysteine, 15x100mm Biplate, 12ml/12ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
Catalog Number
J61
Brand Name
N/A
Version/Model Number
J61
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZI
Product Code Name
Culture Media, Enriched
Public Device Record Key
50a3d916-ce75-46d0-9731-61adda272631
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 24, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |