Remel

GUDID 03848838023009

BactiStaph Latex 150TST/KT

REMEL, INC.

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 03848838023009
• NIH Device Record Key: 30e1ee0d-390c-4907-a4e8-3709f001c285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remel
• Version Model Number: R21144
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 150
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com
• Phone: 8002556730
• Email: csemail@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838023002 [Primary]
GS1	03848838023009 [Unit of Use]

FDA Product Code

• JWX: Kit, Screening, Staphylococcus Aureus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-12

On-Brand Devices [Remel ]

• 03848838063708: Xpect Flu A&B Control 20Swab/SET
• 03848838062503: RapID STAPH PLUS System 20/KT
• 03848838058278: RapID CB PLUS System 20/KT
• 03848838058230: RapID YEAST PLUS System KT/20TST
• 03848838058193: RapID ONE System 20/KT
• 03848838058155: RapID NF PLUS System 20/KT
• 03848838058117: RapID SS/u System KT/20
• 03848838058070: RapID STR System KT/20
• 03848838058032: RapID ANA II System 20/KT
• 03848838027038: Xpect Flu A&B KT/20TST
• 03848838023009: BactiStaph Latex 150TST/KT
• 03848838022989: BactiStaph Latex 450TST/KT
• 30848838063702: Xpect Flu A&B Control 20Swab/SET
• 30848838062507: RapID STAPH PLUS System 20/KT
• 30848838058272: RapID CB PLUS System 20/KT
• 30848838058234: RapID YEAST PLUS System KT/20TST
• 30848838058197: RapID ONE System 20/KT
• 30848838058159: RapID NF PLUS System 20/KT
• 30848838058111: RapID SS/u System KT/20
• 30848838058074: RapID STR System KT/20
• 30848838058036: RapID ANA II System 20/KT
• 30848838027032: Xpect Flu A&B KT/20TST
• 30848838023003: BactiStaph Latex 150TST/KT
• 30848838022983: BactiStaph Latex 450TST/KT
• 30848838068417: Xpect C. diff Toxin A/B KT/40TST
• 30848838028770: Candida albicans screen 50TST/KT
• 30848838028626: LAP Disk w/Reagent 50TST/KT
• 30848838027094: Xpect C. diff Toxin A/B KT/20TST
• 30842558108606: SPECTRA Strep A Agar 10/PK
• 00848838077418: Saline,0.45% (3.0ml) 100/PK
• 00848838066078: Gram Decolorizer, Enhanced BTL/1gallon
• 00848838066061: Gram Decolorizer, Enhanced BTLx5/250ml
• 00848838066054: Gram Crystal Violet-Enhanced BTL/1gallon
• 00848838066047: Gram Crystal Violet, Enhanced BTLx5/250ml
• 00848838066009: TB Methylene Blue BTLx5/250ml
• 00848838065989: TB Decolorizer,Truant-Moore BTLx5/250ml
• 00848838065972: TB Decolorizer (3% acid alc) BTLx5/250ml
• 00848838065965: TB Kinyoun Carbolfuchsin BTLx5/250ml
• 00848838065941: TB Bril Green BTLx5/250ml
• 00848838065934: TB Potassium Permanganate BTLx5/250ml
• 00848838065927: TB Auramine O BTLx5/250ml
• 00848838065903: AFB Stain QC Slide PK/45
• 00848838065897: AFBStain QC Slide PK/10
• 00848838065880: Gram Stain QC Slide PK/45
• 00848838065873: Gram Stain QC Slide PK/10
• 00848838065842: Xylene-S BTL/250ml
• 00848838065835: Ethanol (90%) MeOH (4.5%) IPA (5.5%) BTL/250ml
• 00848838065811: TB Methylene Blue BTL/250ml
• 00848838065804: TB Malachite Green BTL/250ml
• 00848838065798: TB Decolorizer,Truant-Moore BTL/250ml