FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020176
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-15
Catalog number
B1077-15
Device description
SP Staphslide LTX Test 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380020176PrimaryGS10
10885380020179Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538002017620885380020176
1088538002017910885380020179

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
150
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
20885380020237CARDINAL 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