CAPI 3 NEONAT Hb 2506

GUDID 03607360025062

SEBIA

Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis

Primary Device ID	03607360025062
NIH Device Record Key	e72c7c6d-bfca-4622-95ac-95075ccaba9f
Commercial Distribution Status	In Commercial Distribution
Brand Name	CAPI 3 NEONAT Hb
Version Model Number	2506
Catalog Number	2506
Company DUNS	276801933
Company Name	SEBIA
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up_Do Not Freeze_Fragile-handle with care_Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360025062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232027

FDA Product Code

GKA	Abnormal Hemoglobin Quantitation

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	2024-05-08
Device Publish Date	2024-04-30

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03607360047576 - CAPI 3 NEONAT Hb AF Control	2024-05-08
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03607360026014 - ANTISERA CAPI 3 IT (10)	2023-12-07
03607360026021 - Sample Diluent CAPI 3 IT (10)	2023-12-07