AccuDiag™ 310-100

GUDID 00894175000312

AccuDiag™CRP Latex Test Kit C- Reactive Protein (CRP) latex slide test is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.

Diagnostic Automation, Inc.

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 00894175000312
• NIH Device Record Key: c7820512-38b5-4293-83e4-8c25ae2af67d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDiag™
• Version Model Number: DACD310-100
• Catalog Number: 310-100
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com
• Phone: 8185913030
• Email: onestep@rapidtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000312 [Primary]

FDA Product Code

• DCN: System, Test, C-Reactive Protein

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: 2021-09-03
• Device Publish Date: 2021-08-26

On-Brand Devices [AccuDiag™]

• 00894175000381: AccuDiag™ RF Latex Test Kit For the qualitative and semi-quantitative measurement of RF in hum
• 00894175000312: AccuDiag™CRP Latex Test Kit C- Reactive Protein (CRP) latex slide test is used for the qualita
• 00894175000473: AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA Kit A collection of reagents and other ass
• 00894175000527: AccuDiag™Measles IgM ELISA Kit A collection of reagents and other associated materials intende
• 00894175000558: AccuDiag™ Cytomegalovirus IgM ELISA A collection of reagents and other associated materials in
• 00850049545518: AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA
• 00850049545044: AccuDiag™ TSH ELISA -A collection of reagents and other associated materials intended to be us