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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

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