FDA.reportPublic FDA data

Remel

Primary DI
30848838022983
Brand
Remel
Company
REMEL, INC.
Model
R21143
Device description
BactiStaph Latex 450TST/KT
Published
2021-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00848838022982PrimaryGS10
30848838022983Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838022982008488380229828488380229820848838022982
3084883802298330848838022983

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730csemail@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
450
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
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

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
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
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