BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and FN Plus Anaerobic Bottles.

BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and FN Plus Anaerobic Bottles.
Worksafe™ Blood Culture Collection Kits: FAN®PLUS - Worksafe™ Blood Culture Collection Kits: FAN®PLUS

A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OIB

Device Name: Blood And Urine Collection Kit (Excludes Hiv Testing)

Device Class: 1

Physical State: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Submission Type ID: 7

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Regulation Number: 864.3250

Third Party Flag: N

Medical Specialty: PA

Device Id: 03573026601874

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 03573026606466

Package Quantity: 40

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 03573026606466

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A