FDA.reportPublic FDA data

CHROMOSTREAK

Primary DI
07290006418326
Brand
CHROMOSTREAK
Company
SAVYON DIAGNOSTICS LTD
Model
BD-915
Catalog number
BD-915
Device description
Urine culture device for transporting urine samples and for isolating, enumerating and identifying specific bacteria in urine; paddle device with UriSelective agar and MacConkey agar; for professional in vitro diagnostic use.
Published
2026-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSNCulture Media, Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSNCulture Media, Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000718000CHROMOSTREAKNovamed , Ltd.2000-08-24JSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290006418326PrimaryGS10
17290006418323Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290006418326072900064183267290006418326
1729000641832317290006418323

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
533708202
Device count
10
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290006418111DIASLIDE URINE CULTURING DEVICEDS-1052026-05-04
07290013348531URISCREEN 101-012026-04-29
17290006558937Feminine Screening KitF-1-VO-CVS022026-02-22
07290006558930Feminine Screening KitF-1-VO-CVS022026-02-22
07290001913147SeroELISA Chlamydia IgGA111-01A111-012025-05-29
07290001913161SeroELISA Chlamydia IgAA113-012025-05-29
07290013348302Conjugate IgAFA233-12MFA233-12M2023-06-29
07290013348470Conjugate IgMFA232-12MFA232-12M2023-06-29
07290016332193Serum Diluent IgMFB262-03MFB262-03M2023-06-29
07290016332636Bordetella Pertussis IgGA2231-01MA2231-01M2023-06-16
07290013348487Bordetella immunology reagents IgA2233-012233-012023-06-29
07290013348494Bordetella immunology reagents IgM2232-012232-012023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838009518REMELREMEL, INC.JSN2022-12-22
00848838021862REMELREMEL, INC.JSN2022-12-22
00848838021886REMELREMEL, INC.JSN2022-12-22
B08810310InPouch® TVBIO-MED DIAGNOSTICS, INC.JSN2018-08-20