Hb AFSC Control 4792

GUDID 03607360047927

SEBIA

Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control Haemoglobin detection IVD, control

Primary Device ID	03607360047927
NIH Device Record Key	2e2e4fd5-ba45-4d7f-879c-282a981613d6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Hb AFSC Control
Version Model Number	4792
Catalog Number	4792
Company DUNS	276801933
Company Name	SEBIA
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	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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *This Way Up

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360047927 [Primary]

FDA Product Code

JCM	Control, Hemoglobin, Abnormal

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

Devices Manufactured by SEBIA

03607360012444 - CAPILLARYS 3 DBS	2024-05-08 INSTRUMENT
03607360025062 - CAPI 3 NEONAT Hb	2024-05-08
03607360025635 - CAPI 3 NEONAT HEMOLYSING SOLUTION	2024-05-08
03607360025789 - CAPILLARYS 3 DBS MICROPLATES	2024-05-08 MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
03607360047576 - CAPI 3 NEONAT Hb AF Control	2024-05-08
03607360047927 - Hb AFSC Control	2024-05-08
03607360047927 - Hb AFSC Control	2024-05-08
03607360026014 - ANTISERA CAPI 3 IT (10)	2023-12-07
03607360026021 - Sample Diluent CAPI 3 IT (10)	2023-12-07