Kidney Function Test

Primary DI
00810040821004
Brand
Kidney Function Test
Company
Cue Health Inc.
Model
C2236
Device description
Sample Collection Kit, Blood (Adx Single), Kidney Panel
Published
2024-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040821004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040821004008100408210048100408210040810040821004

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection kit IVDA collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081257070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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