DiaSpect Control HBT1 900-501

GUDID 04048534001977

For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes

EKF-diagnostic GmbH

Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control

• Primary Device ID: 04048534001977
• NIH Device Record Key: db3645cb-f1bd-4263-8e4d-ba3dbf41e1af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaSpect Control HBT1
• Version Model Number: 7049-6211
• Catalog Number: 900-501
• Company DUNS: 330046442
• Company Name: EKF-diagnostic GmbH
• Device Count: 3
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de
• Phone: +4939203511414
• Email: support@ekf-diagnostic.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048534001977 [Unit of Use]
GS1	14048534001974 [Primary]

FDA Product Code

• GGM: Control, Hemoglobin

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: 2021-03-22
• Device Publish Date: 2021-03-12

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• 04048534002004 - DiaSpect Control HBT4: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001977 - DiaSpect Control HBT1: 2021-03-22For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001977 - DiaSpect Control HBT1: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001984 - DiaSpect Control HBT2: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes
• 04048534001991 - DiaSpect Control HBT3: 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes