Remel

GUDID 30848838027094

Xpect C. diff Toxin A/B KT/20TST

REMEL, INC.

Clostridium difficile antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 30848838027094
• NIH Device Record Key: af876f15-01b5-46e8-9410-63212e86b403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remel
• Version Model Number: R24650
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 20
• 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: true
• 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: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com
• Phone: 8002556730
• Email: csemal@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838027093 [Primary]
GS1	30848838027094 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041951

FDA Product Code

• LLH: Reagents, Clostridium Difficile Toxin

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: 2022-04-29
• Device Publish Date: 2022-04-21

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