FDA.report

Monobind AccuBind T4 SBS ELISA Kit - 192 Wells

Primary DI
00816870021706
Brand
Monobind AccuBind T4 SBS ELISA Kit - 192 Wells
Company
MONOBIND, INC.
Model
8225-300
Catalog number
8225-300B
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CDXRadioimmunoassay, total thyroxine

Product Code Classifications

CodeDeviceSpecialtyClass
CDXRadioimmunoassay, Total ThyroxineClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816870021706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870021706008168700217068168700217060816870021706

GMDN Terms

TermDefinition
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes

TypeValueUnit
Width7.75Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)951-2665info@monobind.com

Regulatory Flags

DUNS number
083155515
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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