Hemocytometer (CE) Fuchs-Rosenthal brightline

GUDID 04061609000385

BIOANALYTIC GmbH, biomed. Analysentechnik

Microscope counting chamber IVD

• Primary Device ID: 04061609000385
• NIH Device Record Key: 89063718-726a-43fd-820f-cbcfe7f387a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemocytometer (CE) Fuchs-Rosenthal brightline
• Version Model Number: CC.FUROB
• Company DUNS: 327536728
• Company Name: BIOANALYTIC GmbH, biomed. Analysentechnik
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04061609000385 [Primary]

FDA Product Code

• GHO: Hemocytometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-06

Devices Manufactured by BIOANALYTIC GmbH, biomed. Analysentechnik

• 04061609000699 - Thrombo-TIC 1:100 pur: 2019-03-04
• 04061609000712 - Thrombo-TIC 1:25 pur: 2019-03-04
• 04061609000736 - Thrombo-TIC 1:25 pur: 2019-03-04
• 04061609000019 - Sperm-TIC 1:20: 2018-03-29 For microscopic counting of Sperms. (5 Tests)
• 04061609000026 - Sperm-TIC 1:20 plus: 2018-03-29 For microscopic counting of Sperms. (100 Tests)
• 04061609000033 - Ejaculate-TIC 1:20: 2018-03-29
• 04061609000040 - Ejaculate-TIC 1:20 plus: 2018-03-29
• 04061609000057 - Leuko-TIC VT: 2018-03-29