FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020237
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-50
Catalog number
B1077-50
Device description
SP Staphslide LTX Test 50 Determination
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWXKIT, SCREENING, STAPHYLOCOCCUS AUREUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWXKit, Screening, Staphylococcus AureusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855220000V-TREND KIT STAPH LATEX TESTTexas Immunology, Inc.1986-03-03JWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380020237PrimaryGS10
10885380020230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538002023720885380020237
1088538002023010885380020230

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus culture isolate antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1000
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384029044STAPHYTECT PLUSOXOID LIMITEDJWX2026-01-28
05032384029051STAPHYTECT PLUSOXOID LIMITEDJWX2026-01-28
00816057021826ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00816057021833ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00816057021840ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00848838022982Remel REMEL, INC.JWX2021-11-12
00848838023002Remel REMEL, INC.JWX2021-11-12
30848838022983Remel REMEL, INC.JWX2021-11-12
30848838023003Remel REMEL, INC.JWX2021-11-12
03848838022989Remel REMEL, INC.JWX2021-11-12
03848838023009Remel REMEL, INC.JWX2021-11-12
05056080501512Staphaurex Plus (150 test)REMEL EUROPE LIMITEDJWX2021-07-21
05056080501529Staphaurex Plus (450 test)REMEL EUROPE LIMITEDJWX2021-07-21
03573026588601ID 32 STAPHBIOMERIEUX SAJWX2020-04-10
03573026048259API® StaphBIOMERIEUX SAJWX2020-04-10
03573026066499ID 32 STAPHBIOMERIEUX SAJWX2020-04-10
20885380020176CARDINAL HEALTHCardinal Health 200, LLCJWX2016-09-15
00816057020065ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020072ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020089ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020096ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020102ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020119ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057021581ASI Staphslide Control SetARLINGTON SCIENTIFIC, INC.JWX2016-07-08